Postmarketing Requirements and Commitments - 博彩app软件下载

When the 博彩app软件下载 Food and Drug Administration grants marketing approval to a new drug or biologic, it may condition that approval on the sponsor’s commitment to conduct certain future studies and clinical trials, in order to generate additional useful data on the safety, efficacy or optimal use of the medicine. Some of these studies and clinical trials may be required. This website provides information on 博彩app软件下载app软件下载 Myers Squibb’s 博彩app软件下载 postmarketing requirements and commitments. These studies build on the data that was submitted for approval.

The data available on this site includes:

  • Product (generic and trade name)
  • Description of the Requirement or Commitment
  • Projected Completion Date
  • Study Status
  • Relevant or explanatory notes, if any

Differences may be noted between the status of a requirement or commitment reported here compared to the status as reported on the FDA website. This is usually a result of the fact that the FDA requires time to review the data, as well as update its website.

The 博彩app软件下载app软件下载 Myers Squibb website focuses on clinical and other studies related to the safety, efficacy and use of the medicine. It does not list commitments related to manufacturing issues, known as “Chemistry, Manufacturing and Controls”. Also, this site lists commitments only for those products 博彩app软件下载app软件下载 Myers Squibb is the sponsor holding the 博彩app软件下载 regulatory approval for the medicine.

This site will be updated twice/year to reflect the most current information. Once the FDA determines that a requirement or commitment is fulfilled or they release the company from its commitment, it will be removed from the website.

博彩app软件下载 Postmarketing Requirement and Commitment Studies


Abatacept

Generic Name
ABATACEPT
Trade Name
ORENCIA
Projected Completion Date
30-Jun-29
Study Status
Ongoing

Description of Commitment

Submission of the protocol, interim reports, and final study report for a JIA patient safety registry comprised of at least 500 patients.  This protocol should include a plan for more intensive scrutiny for the first 3 years, with annual follow ups (which could be telephonic) assessing for occurrence of malignancies, other autoimmune diseases, and serious infections, for a total of 10 years.  Patients turning 18 years of age or older should continue to be followed until they have completed the 10 year follow-up period.  Information on these patients may be obtained via annual questionnaire/ telephonic follow-up with attention to key adverse events rather than full clinic visit with examination.  Protocol Submission:  December 31, 2008; Study Start:  June 30, 2009; Interim Report Submissions: June 30, 2014/2019/2024; Final Report Submission: June 30, 2029.

Generic Name
ABATACEPT
Trade Name
ORENCIA
Projected Completion Date
30-Jun-29
Study Status
Ongoing

Description of Commitment

Observational study in pediatric patients 2 to 5 years of age with juvenile idiopathic arthritis (JIA) treated with abatacept to evaluate the long term safety of abatacept, with respect to the risk of malignancies, autoimmune diseases, and serious infections.


Apixaban

Generic Name
APIXABAN
Trade Name
ELIQUIS
Projected Completion Date
31-Dec-20
Study Status
Ongoing

Description of Commitment

Assess apixaban pharmacokinetics and pharmacodynamics in approximately 50 pediatric subjects aged 0 to less than 18 years, who are at risk for a venous or arterial thrombotic disorder, to determine dosing requirements for subsequent studies in children. Completion and submission of results of Study CV185118 and available data from CV185079 may be used to fulfill this requirement.

Generic Name
APIXABAN
Trade Name
ELIQUIS
Projected Completion Date
18-Oct-21
Study Status
Ongoing

Description of Commitment

Conduct a randomized, open-label, active-controlled, safety and descriptive efficacy study to assess apixaban treatment in 150 pediatric patients evaluable for efficacy and safety, aged 0 to less than 18 years, requiring anticoagulation for the treatment of a venous thromboembolic event (VTE). This trial will also evaluate apixaban pharmacokinetics, anti-Factor Xa activity, and imaging assessment of clot status at the end of treatment in pediatric patients requiring anticoagulation for the treatment of a VTE. Completion and submission of results of Study CV185325 may be used to fulfill this requirement.

 Atazanavir / Cobicistat

Generic Name
ATAZANAVIR/ COBICISTAT
Trade Name
EVOTAZ
Projected Completion Date
31-Oct-23
Study Status
Ongoing

Description of Commitment

Evaluate the pharmacokinetics, safety, and antiviral activity (efficacy) of atazanavir and cobicistat fixed-dose combination (FDC) age-appropriate formulation in HIV-infected pediatric subjects 3 years to less than 6 years of age. The safety and antiviral activity (efficacy) of atazanavir and cobicistat FDC age-appropriate formulation in pediatric subjects should be evaluated for a minimum of 24 weeks. A clinical trial in children 3 years to less than 6 years of age may not be required if the dosing recommendation for the FDC age-appropriate formulation can be supported by pediatric trials already conducted with the individual drug products and if the age-appropriate FDC produces similar exposures as the individual components.


Generic Name
ATAZANAVIR/ COBICISTAT
Trade Name
EVOTAZ
Projected Completion Date
31-Oct-23
Study Status
Ongoing

Description of Commitment

Evaluate the pharmacokinetics, safety, and antiviral activity (efficacy) of atazanavir and cobicistat fixed-dose combination (FDC) age-appropriate formulation in HIV-infected pediatric subjects 6 years to less than 12 years of age. The safety and antiviral activity (efficacy) of atazanavir and cobicistat FDC age-appropriate formulation in pediatric subjects should be evaluated for a minimum of 24 weeks. A clinical trial in children 6 years to less than 12 years of age may not be required if the dosing recommendation for the FDC age-appropriate formulation can be supported by pediatric trials already conducted with the individual drug products and if the age-appropriate FDC produces similar exposures as the individual components.

Generic Name
ATAZANAVIR/ COBICISTAT
Trade Name
EVOTAZ
Projected Completion Date
30-Sep-20
Study Status
Ongoing

Description of Commitment

Evaluate the pharmacokinetics, safety, and antiviral activity (efficacy) of atazanavir and cobicistat fixed-dose combination (FDC) age-appropriate formulation in HIV-infected pediatric subjects 12 years to less than 18 years of age. The safety and antiviral activity (efficacy) of atazanavir and cobicistat FDC age-appropriate formulation in pediatric subjects should be evaluated for a minimum of 24 weeks. A clinical trial in children 12 years to less than 18 years of age may not be required if the dosing recommendation for the FDC age-appropriate formulation can be supported by pediatric trials already conducted with the individual drug products and if the age-appropriate FDC produces similar exposures as the individual components.


Belatacept

Generic Name
BELATACEPT
Trade Name
NULOJIX
Projected Completion Date
30-Apr-20
Study Status
Submitted

Description of Commitment

Conduct a prospective observational study utilizing data from the United Network for Organ Sharing (UNOS) on the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in US adult kidney-only transplant recipients who are treated with belatacept compared to recipients treated with calcineurin inhibitor (CNI)-based regimens. Recipient characteristics will be collected, including EBV and CMV serostatus, location of the PTLD, and outcome (survival or mortality). Incidence rates of PTLD in belatacept-exposed patients will be quantified beginning when 500 belatacept-exposed patients have at least 1 year of follow-up. Relative risks of PTLD for belatacept compared to CNI-based regimens will be estimated after 1,000 person years have been accumulated in transplant recipients initiated on belatacept at transplantation. (Protocol Number IM103075).

Generic Name
BELATACEPT
Trade Name
NULOJIX
Projected Completion Date
30-Apr-20
Study Status
Fulfilled

Description of Commitment

Conduct a prospective registry of belatacept use in US adult kidney-only transplant recipients to determine the incidence rates of post-transplant lymphoproliferative disorder PTLD, PTLD in the central nervous system (CNS PTLD), and progressive multifocal leukoencephalopathy (PML) in US adult EBV seropositve kidney transplant recipients treated with belatacept in clinical practice. All US adult kidney transplant centers dispensing belatacept will be asked to participate in the study (i.e., if a center does not respond or declines to participate, the reason(s) for nonparticipation will be identified and documented). Recipient characteristics will be collected, including EBV and CMV serostatus, timing of initiation of belatacept in relation to the transplant, location of the PTLD, and outcome (survival or mortality). (Protocol Number IM13076).


Dasatinib

Generic Name
DASATINIB
Trade Name
SPRYCEL
Projected Completion Date
31-Mar-21
Study Status
Ongoing

Description of Commitment

Generate additional PK data for dasatinib powder for oral suspension (PFOS) in pediatric patients with CML or Ph+ ALL at a dosage of 90 mg/m2/day. Submit a final report and datasets for the PK substudy of CA180226.


Elotuzumab 

Generic Name
ELOTUZUMAB
Trade Name
EMPLICITI
Projected Completion Date
30-Sep-20
Study Status
Ongoing

Description of Commitment

Conduct an elotuzumab exposure-response analysis for efficacy and safety utilizing data from trial CA204006. The result of the exposure-response analyses from both CA204004 and CA204006 will be used to determine whether a post-marketing trial is needed to optimize the dose in patients with multiple myeloma who have low exposure to elotuzumab at the approved dose (10 mg/kg). Submit a final report of the exposure-response analyses based on CA204004 and CA 204006.

Generic Name
ELOTUZUMAB
Trade Name
EMPLICITI
Projected Completion Date
31-Mar-19
Study Status
Submitted

Description of Commitment

Evaluate if the current neutralizing antibody assay cut-point is appropriate to analyze clinical study CA204125 samples that confirm positive for anti-drug antibodies (ADA) to elotuzumab. If the current cut-point is determined to not be acceptable, re-determine the cut-point based on the analysis of pre-dose clinical study CA204125 samples, re-analyze the neutralizing antibody assay results of the confirmed positive ADA clinical study CA204125 samples using the new neutralizing antibody cut-point, and update the BLA accordingly based on the reanalysis of the CA204125 samples.


Enasidenib

Generic Name
ENASIDENIB
Trade Name
IDHIFA
Projected Completion Date
31-Dec-20
Study Status
Ongoing

Description of Commitment

Conduct a meta-analysis to characterize enasidenib-related differentiation syndrome, specifically incidence, appropriate diagnostic criteria, and effective treatment based on patient-level data and pooled analyses for on-going trials in patients with acute myeloid leukemia: AG221-C-001, AG-120-221-C-001, AG-221-AML-004, and AG-221-AML-005. Submit the study report and analysis data set.

Generic Name
ENASIDENIB
Trade Name
IDHIFA
Projected Completion Date
31-Mar-20
Study Status
Fulfilled

Description of Commitment

Characterize the long-term safety of enasidenib in patients with relapsed or refractory acute myeloid leukemia (AML). Submit the final study report and data set with 3 years of follow-up from ongoing Study AG221-C-001, A phase 1/2, multi-center, open-label, dose-escalation and expansion, safety, pharmacokinetic, pharmacodynamics, and clinical activity study of orally administered AG-221 in subjects with advanced hematologic malignancies with an IDH2 mutation. Include data from approximately 280 patients with relapsed or refractory AML. 

Generic Name
ENASIDENIB
Trade Name
IDHIFA
Projected Completion Date
31-Jul-23
Study Status
Ongoing

Description of Commitment

Conduct a trial to provide evidence sufficient to characterize the long-term safety of enasidenib compared to conventional care regimens in patients with acute myeloid leukemia (AML). Submit the final study report and data set with 3 years of follow-up from on-going Study AG-221-AML-004, A phase 3, multicenter, open-label, randomized study comparing the efficacy and safety of AG-221 versus conventional care regimens in older subjects with late stage acute myeloid leukemia harboring an isocitrate dehydrogenase 2 mutation. Include data from approximately 140 patients with relapsed or refractory AML. Include in the final study report the exploratory subgroup analyses and corresponding subject-level data related to pre- and post-treatment cytogenetics, specific IDH2 mutations, and mutation analyses for other genes (e.g., IDH2, FLT3, NPM1, CEBPA, DNMT3A, NRAS) as obtained under the trial protocol or from medical history prior to trial enrollment.

Generic Name
ENASIDENIB
Trade Name
IDHIFA
Projected Completion Date
30-Jun-21
Study Status
Ongoing

Description of Commitment

Conduct clinical pharmacokinetic trials to evaluate the effect of multiple doses of enasidenib on the single dose pharmacokinetics of sensitive substrates CYP3A4, CYP2D6, CYP2C19, CYP2C9,UGTs, P-gp, and BCRP to address the potential for excessive drug toxicity. This trial should be designed and conducted in accordance with the FDA Guidance for Industry entitled "Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations."

Generic Name
ENASIDENIB
Trade Name
IDHIFA
Projected Completion Date
28-Feb-23
Study Status
Ongoing

Description of Commitment

Conduct a clinical pharmacokinetic trial to determine an appropriate dose of enasidenib in patients with hepatic impairment. This trial should be designed and conducted in accordance with the FDA Guidance for Industry entitled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling."


Fedratinib

Generic Name
FEDRATINIB
Trade Name
INREBIC
Projected Completion Date
30-Jun-25
Study Status
Pending

Description of Commitment

Conduct a randomized, concurrently controlled clinical trial comparing fedratinib 400 mg once daily to best available therapy in patients with DIPSS-intermediate-2 or high-risk primary myelofibrosis, postpolycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib. The trial will enroll a sufficient number of patients to ensure that at least 150 subjects are treated with at least 6 cycles of febratinib and are followed for at least 3 years from first dose, or until death. The protocol should include measures to assess and manage adverse events of nausea, diarrhea, vomiting, thiamine deficiency, and encephalopathy at baseline and during the trial. The final protocol must be agreed upon with the Agency.

Generic Name
FEDRATINIB
Trade Name
INREBIC
Projected Completion Date
30-Jun-22
Study Status
Pending

Description of Commitment

Conduct a clinical pharmacokinetic trial to determine an appropriate dose of fedratinib to minimize toxicity in subjects with severe hepatic impairment. Design and conduct the trial in accordance with the FDA guidance for industry entitled, Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling.

Generic Name
FEDRATINIB
Trade Name
INREBIC
Projected Completion Date
28-Feb-22
Study Status
Pending

Description of Commitment

Conduct a clinical trial to evaluate the effect of coadministration of a dual CYP2C19 and CYP3A4 inhibitor on the pharmacokinetics and safety of a single dose of fedratinib. Design and conduct the trial in accordance with the FDA guidance for industry entitled, Clinical Drug Interaction Studies - Study Design, Data Analysis, and Clinical Implications. In addition, conduct physiologically based pharmacokinetic (PBPK) modeling using data from the clinical trial to determine an appropriate dose of fedratinib in patients dosed with fedratinib at steady state and coadministered with multiple doses of dual CYP2C19 and CYP3A4 inhibitor in accordance with FDA guidances for industry entitled, In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies and Physiologically Based Pharmacokinetic Analyses - Format and Content.

Generic Name
FEDRATINIB
Trade Name
INREBIC
Projected Completion Date
30-Sep-21
Study Status
Pending

Description of Commitment

Conduct a clinical trial to evaluate the effect of single dose of fedratinib on the single dose pharmacokinetics and safety of sensitive substrates of P-gp, BCRP, MATE-1/2K, and OCT2 transporters. Design and conduct the trial in accordance with the FDA guidance for industry entitled, Clinical Drug Interaction Studies - Study Design, Data Analysis, and Clinical Implications.

Generic Name
FEDRATINIB
Trade Name
INREBIC
Projected Completion Date
30-Jun-21
Study Status
Pending

Description of Commitment

Conduct a clinical pharmacokinetic trial to determine an appropriate dose of fedratinib when fedratinib is coadministered with and without multiple doses of strong and moderate CYP3A4 inducers. Design and conduct the trial in accordance with the FDA guidance for industry entitled, Clinical Drug Interaction Studies - Study Design, Data Analysis, and Clinical Implications. 


Ipilimumab

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-Dec-18
Study Status
Fulfilled

Description of Commitment

To identify further genetic determinants of immune-mediated adverse events caused by ipilimumab. DNA samples from the required postmarketing study comparing 3 mg/kg vs. 10 mg/kg ipilimumab monotherapy will be used to conduct genome-wide association analyses. The design of these analyses will be reviewed by FDA and a final report with electronic datasets will be provided.

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-May-24
Study Status
Ongoing

Description of Commitment

Conduct a Pregnancy Pharmacovigilance Study to evaluate pregnancy outcomes and infant outcomes following exposure to Yervoy (ipilimumab). This study will include a mechanisn to collect, classify, and analyze data on direct exposures (women exposed to ipilimumab as treatment). There will be interim annual reporting of the data collected from the study. The study, at a minimum, will include the following key elements: Data collection of prospective and retrospective data points, adequate to produce informative, reliable data outcomes; Data analysis utilizing descriptive statistics for summarizing data that will fully capture outcomes of concern. Data collected prospectively will be analyzed separately from data collected retrospectively; Description of procedures including patient recruitment, along with healthcare provider awareness of the potential safety risk and existence of this study, and the monitoring of pregnancy and infant outcomes.

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
28-Feb-20
Study Status
Submitted

Description of Commitment

Submit final overall survival analysis and datasets to include both intermediate/poor risk ITT population with the final report from the updated survival follow-up from clinical trial Checkmate-214, entitled; "CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 214."

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
30-Apr-21
Study Status
Ongoing

Description of Commitment

Submit the final clinical report and datasets of Trial E1609, entitled "A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High Dose Interferon a-2b for Resected High Risk Melanoma" to inform any change to the recommended dose of Yervoy (ipilimumab) for adjuvant treatment of resected Stage III melanoma patients, if required, based on the final results of Trial E1609. 

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Submit the final report, including datasets, from a randomized trial conducted to verify and describe the clinical benefit of ipilimumab, administered in combination with nivolumab, in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. The trial will be designed to demonstrate a clinically meaningful improvement in progression-free survival in patients randomized to receive ipilimumab and nivolumab as compared to patients randomized to receive nivolumab alone. In addition, the trial should evaluate for differences in overall survival between arms based on a pre-specified analysis. The analysis plan should describe the power for the overall survival analysis, as well as all assumptions made in determining the power.

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-Jul-19
Study Status
Submitted

Description of Commitment

Submit the final report, including datasets, from trials conducted to describe the clinical benefit of ipilimumab, administered in combination with nivolumab, in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. This report is to include data on 119 patients with microstatellite instability-high or mismatch repair deficient metastatic colorectal cancer enrolled in Study CA209142 whose preliminary results are described in current labeling and on the 82-patient subset of these 119 patients who experienced disease progression on 5FU, oxaliplatin, and irinotecan. The final report will provide updated data on all responding patients who will be followed for at least 12 months from the onset of response.

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Commitment to support the availability through an appropriate analytical and clinical validation study using clinical trial data that will support labeling of an immunohistochemistry-based in vitro diagnostic device that is essential to the safe and effective use of ipilimumab for patients with tumors that are mismatch repair deficient.

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Commitment to support the availability through an appropriate analytical and clinical validation study using clinical trial data that will support labeling of a nucleic acid-based in vitro diagnostic device that is essential to the safe and effective use of ipilimumab for patients with tumors that are microsatellite instability-high.

Generic Name
IPILIMUMAB
Trade Name
YERVOY
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Submit the final report demonstrating an improvement in overall survival from a multicenter, randomized trial to confirm the clinical benefit of ipilimumab in combination with nivolumab over standard therapy in patients with advanced hepatocellular carcinoma, that may inform product labeling. Submit the datasets with the final report.


Luspatercept

Generic Name
LUSPATERCEPT
Trade Name
REBLOZYL
Projected Completion Date
31-Oct-20
Study Status
Pending

Description of Commitment

Complete Study A536-06: An Open-Label Extension Study to Evaluate the Effects of ACE-536 in Patients with Beta-Thalassemia. Include all the patients from Study A536-04 who enrolled into the open-label extension study (A536-06). Include summary analysis and updated safety summary to include safety data on thrombosis, all malignancies (including AML), hepatic toxicity, and renal toxicity. Include updated assessments of ferritin levels, liver iron concentrations and use of chelators evaluations in the reports. Include updated safety and efficacy analysis and submit datasets at the time of final clinical study report submission.

Generic Name
LUSPATERCEPT
Trade Name
REBLOZYL
Projected Completion Date
31-Dec-20
Study Status
Delayed

Description of Commitment

Complete Trial ACE-536-B-THAL-001: Phase 3, Randomized, Placebo-Controlled, Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults who Require Regular Blood Transfusions. Evaluate safety and efficacy data for the patients who enrolled in the open-label treatment for up to five years. Include summary analysis and updated safety summary to include safety data on thrombosis, all malignancies (including AML), hepatic toxicity, and renal toxicity. Include updated assessments of ferritin levels, liver iron concentrations and use of chelators and any cardiac iron evaluations in the reports. Include updated safety and efficacy analysis and submit datasets at the time of final clinical study report submission.

Explanatory Note

Trial completion and final clinical study report will be delayed due to COVID19. Notified FDA and requested revised milestone dates. FDA acknowledged request and advised that we confirm the revised milestone date and status of the study within 90 days of the original milestone due date.

 

Generic Name
LUSPATERCEPT
Trade Name
REBLOZYL
Projected Completion Date
30-Sep-23
Study Status
Pending

Description of Commitment

Complete Trial ACE-536-B-THAL-002: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) versus Placebo in Adults with non-Transfusion Dependent Beta (B) Thalassemia.  Include summary analysis and updated safety summary to include safety data on thrombosis, all malignancies (including AML), hepatic toxicity, and renal toxicity. Include updated assessments of ferritin levels, liver iron concentrations and use of chelators and any cardiac iron evaluations in the reports. Include updated safety and efficacy analysis and submit datasets at the time of final clinical study report submission.

Generic Name
LUSPATERCEPT
Trade Name
REBLOZYL
Projected Completion Date
31-Dec-24
Study Status
Pending

Description of Commitment

Conduct an assessment of cases of secondary primary malignancies (and malignancies for B-thalassemia), to include hematological malignancies (AML, de-nono AML, transformation to AML), and solid tumors identified in sponsor-initiated and investigator-initiated clinical trials across the entire luspatercept development program for 5 years post approval.

Generic Name
LUSPATERCEPT
Trade Name
REBLOZYL
Projected Completion Date
31-Mar-23
Study Status
Pending

Description of Commitment

Characterize the long-term safety of luspatercept-aamt in patients with myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic syndromes/myeloproliferative neoplasm with RS and thrombocytosis (MDS/MPN-RS-T). Complete Study ACE-536-MDS-001 with at least 5 years of follow-up for enrolled subjects. Submit datasets with the final clinical study report. In the final clinical study report, include subgroup analyses of transformation to higher-risk MDS or acute myeloid leukemia and of time to development of second primary malignancies by disease and by baseline transfusion burden.


Nivolumab

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Dec-21
Study Status
Ongoing

Description of Commitment

An Enhanced Pharmacovigilance Study to evaluate the risks factors and clinical sequelae of immune-mediated encephalitis following exposure to OPDIVO (nivolumab). This study will include a mechanism to collect, classify, and analyze data on moderate to severe neurologic deterioration in patients exposed to OPDIVO (nivolumab). The study at a minimum will include the following key elements: a. Data collection of retrospective data points including Brain imaging, specifically magnetic resonance imaging (MRI) with and without gadolinium contrast, and with diffusion weighted imaging (DWI). Results of lumbar puncture including: Cell counts, protein, glucose; Viral encephalitis panel; JC virus detection; Autoimmune/ paraneoplastic encephalitis panel. Results of serum studies including: JC virus detection, Autoimmune/ paraneoplastic encephalitis panel, Vitamin deficiency studies [thiamine, niacin, and B12]. Results of complete neurologic examinations. Concomitant medication use, including use of steroids or other immunemodulating therapies. b. Data analysis utilizing descriptive statistics for summarizing data that will fully capture the outcome of concern.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Dec-26
Study Status
Ongoing

Description of Commitment

Conduct a randomized phase 3 clinical trial in classical Hodgkin lymphoma that verifies and isolates the clinical benefit of nivolumab for patients with classical Hodgkin lymphoma. The primary endpoint would be progression-free survival as determined by an independent review committee. Overall survival would be a key secondary endpoint.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Dec-22
Study Status
Ongoing

Description of Commitment

Characterize complications after allogeneic hematopoietic stem cell transplantation (HSCT) following nivolumab in at least 90 patients with classical Hodgkin lymphoma, of which at least 50% have received nivolumab alone or in combination as the regimen immediately prior to the allogeneic HSCT conditioning regimen. Evaluate toxicities at least through transplant Day 180, and include details of prior nivolumab treatment and the transplant regimen. Characterize toxicities including hyperacute graft-versus-host disease (GVHD), severe (grade III-IV) acute GVHD, febrile syndromes treated with steroids, immune mediated adverse events, pulmonary complications, hepatic veno-occlusive disease, critical illness, and transplant-related mortality. Toxicities may be characterized prospectively, or through a combination of prospective and retrospective data analysis.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
28-Feb-22
Study Status
Ongoing

Description of Commitment

Submit the final report with datasets for the clinical trial entitled "CA209274: A Phase 3 Randomized, Double-blind, Multi-centeer Study of Adjuvant Nivolumab Versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma", examining the effect on disease-free survival.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
30-Sep-21
Study Status
Ongoing

Description of Commitment

Submit the final report, including datasets, from trials conducted to verify and describe the clinical benefit of nivolumab 240mg intravenously every two weeks in patients with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer who have progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan, including at least 150 patients enrolled in BMS-initiated trials, in order to characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
30-Sep-21
Study Status
Ongoing

Description of Commitment

Commitment to support the availability through an appropriate analytical and clinical validation study using clinical trial data that will support labeling of immunohistochemistry based in vitro diagnostic device that is essential to the safe and effective use of nivolumab for patients with tumors that are mismatch repair deficient.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
30-Sep-21
Study Status
Ongoing

Description of Commitment

Commitment to support the availability through an appropriate analytical and clinical validation study using clinical trial data that will support labeling of a nucleic acid-based in vitro diagnostic device that is essential to the safe and effective use of nivolumab for patients with tumors that are microsatellite instability high.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
30-Sep-20
Study Status
Ongoing

Description of Commitment

Conduct and submit the results, including datasets, of a multicenter, randomized trial or trials to verify and describe the clinical benefit of nivolumab over standard therapy based on an improvement in overall survival in patients with advanced hepatocellular carcinoma.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Aug-19
Study Status
Fulfilled

Description of Commitment

Submit the final report, including datasets, for patients with hepatocellular carcinoma who have progressed on, or are intolerant to sorafenib and who received nivolumab 3 mg/kg in the dose escalation or dose expansion phase of CHECKMATE-040. In order to further characterize the duration of response in patients who achieve a complete or partial response to nivolumab, duration of response will be assessed by independent central review and responding patients will be followed for at least 12 months from the onset of response.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
30-Sep-20
Study Status
Ongoing

Description of Commitment

Submit the final clinical report and datasets at the time of the final analysis for overall survival (OS) of Trial CA209238, entitled "A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIB/C or Stage IV Melanoma in Subjects who are at High Risk for Recurrence (CheckMate 238)", to revise the product label with mature OS data.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
30-Sep-18
Study Status
Fulfilled

Description of Commitment

Submit the results of a randomized clinical trial with active control in PD-L1 negative patients with metastatic squamous cell carcinoma of the head and neck (SCCHN) designed to assess for differences in overall survival (OS) as compared to investigator's choice of chemotherapy, to verify the clinical benefit of nivolumab in this patient population.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
28-Feb-20
Study Status
Fulfilled

Description of Commitment

Submit final overall survival analysis and datasets to include both intermediate/poor risk ITT population with the final report from the updated survival follow-up from clinical trial Checkmate-214, entitled; "CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 214."

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Submit the final report, including datasets, from a randomized trial conducted to verify and describe the clinical benefit of nivolumab, administered in combination with ipilimumab, in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. The trial will be designed to demonstrate a clinically meaningful improvement in progression-free survival in patients randomized to receive nivolumab and ipilimumab as compared to patients randomized to receive nivolumab alone. In addition, the trial should evaluate for differences in overall survival between arms based on a pre-specified analysis. The analysis plan should describe the power for the overall survival analysis, as well as all assumptions made in determining the power.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Jul-19
Study Status
Submitted

Description of Commitment

Submit the final report, including datasets, from trials conducted to describe the clinical benefit of nivolumab, administered in combination with ipilimumab, in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. This report is to include data on 119 patients with microstatellite instability-high or mismatch repair deficient metastatic colorectal cancer enrolled in Study CA209142 whose preliminary results are described in current labeling and on the 82-patient subset of these 119 patients who experienced disease progression on 5FU, oxaliplatin, and irinotecan. The final report will provide updated data on all responding patients who will be followed for at least 12 months from the onset of response.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Commitment to support the availability through an appropriate analytical and clinical validation study using clinical trial data that will support labeling of an immunohistochemistry-based in vitro diagnostic device that is essential to the safe and effective use of nivolumab for patients with tumors that are mismatch repair deficient.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Commitment to support the availability through an appropriate analytical and clinical validation study using clinical trial data that will support labeling of a nucleic acid-based in vitro diagnostic device that is essential to the safe and effective use of nivolumab for patients with tumors that are microsatellite instability-high.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Jul-19
Study Status
Ongoing

Description of Commitment

Conduct and submit the results of at least one multicenter, randomized clinical trial establishing the superiority of nivolumab over available therapy as determined by an improvement in overall survival in patients with stage IV small cell lung carcinoma.

Explanatory Note

The confirmatory trials did not meet the primary endpoints. BMS is in discussion with the FDA on a new study to fulfill this PMR. A proposed draft protocol for the FDA review was submitted on 31-Jul-2019.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Oct-19
Study Status
Fulfilled

Description of Commitment

Submit the final report, including datasets, for CHECKMATE-032, in which all 13 of the 109 responding patients identified in the interim study report submitted to BLA 125554/ S-067, have been followed for a minimum of 24 months, to more accurately characterize the BIRC-assessed durability of the response observed with nivolumab, as a single agent, for the third-line treatment of small cell lung cancer for inclusion in product labeling.

Generic Name
NIVOLUMAB
Trade Name
OPDIVO
Projected Completion Date
31-Jul-24
Study Status
Ongoing

Description of Commitment

Submit the final report demonstrating an improvement in overall survival from a multicenter, randomized trial to confirm the clinical benefit of nivolumab in combination with ipilimumab over standard therapy in patients with advanced hepatocellular carcinoma, that may inform product labeling. Submit the datasets with the final report.


Ozanimod

Generic Name
OZANIMOD
Trade Name
ZEPOSIA
Projected Completion Date
30-Jun-22
Study Status
Pending

Description of Commitment

A juvenile animal toxicology study of ozanimod in rat.

Generic Name
OZANIMOD
Trade Name
ZEPOSIA
Projected Completion Date
31-Mar-34
Study Status
Pending

Description of Commitment

A two-part study of Zeposia (ozanimod) in pediatric patients with relapsing forms of multiple sclerosis (RMS) at least 10 years and less than 18 years of age. Part A is an open-label study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Zeposia (ozanimod) in pediatric patients. Part A will include two cohorts, one with body weights less than 40 kg and the other with body weights 40 kg or more. The objective of Part A is to determine titration and maintenance doses of Zeposia (ozanimod) that will result in PK and PD effects that are comparable to those of the 8-day titration administered to adult patients. Part B is a randomized, double-blind, parallel-group study to evaluate the efficacy and safety of Zeposia (ozanimod) compared to an appropriate comparator.

Generic Name
OZANIMOD
Trade Name
ZEPOSIA
Projected Completion Date
30-Jun-33
Study Status
Pending

Description of Commitment

Prospective pregnancy exposure registry cohort analyses in the United States that compare the maternal, fetal, and infant outcomes of women with multiple sclerosis exposed to Zeposia (ozanimod) during pregnancy with two unexposed control populations: one consisting of women with multiple sclerosis who have not been exposed to Zeposia (ozanimod) before or during pregnancy and the other consisting of women without multiple sclerosis.The registry will identify and record pregnancy complications, major and minor congenital malformations, spontaneous abortions, stillbirths, elective terminations, preterm births, small-for-gestational-age births, and any other adverse outcomes, including postnatal growth and development. Outcomes will be assessed throughout pregnancy. Infant outcomes, including effects on postnatal growth and development, will be assessed through at least the first year of life.

Generic Name
OZANIMOD
Trade Name
ZEPOSIA
Projected Completion Date
30-Jun-33
Study Status
Pending

Description of Commitment

A pregnancy outcomes study using a different study design than provided for in PMR 3809-3 (for example, a retrospective cohort study using claims or electronic medical record data with outcome validation or a case-control study) to assess major congenital malformations, spontaneous abortions, stillbirths, preterm births, and small-for-gestational-age births in women exposed to Zeposia (ozanimod) during pregnancy compared to an unexposed control population.

Generic Name
OZANIMOD
Trade Name
ZEPOSIA
Projected Completion Date
31-Oct-22
Study Status
Pending

Description of Commitment

A randomized, double-blind, placebo-controlled, active-controlled (phenelzine), multiple-dose, parallel-group trial to investigate the pressor effect of oral tyramine during Zeposia (ozanimod) treatment in healthy subjects.

Generic Name
OZANIMOD
Trade Name
ZEPOSIA
Projected Completion Date
31-Aug-22
Study Status
Pending

Description of Commitment

A multiple-dose trial to assess the effect of hepatic impairment on the pharmacokinetics (PK) of Zeposia (ozanimod) and its major metabolites and to determine whether a dosing adjustment of Zeposia (ozanimod) is needed in patients with hepatic impairment. The effect of hepatic impairment on the PK of CC112273 and CC1084037 should be assessed after the 1 mg Zeposia (ozanimod) dose administration on Day 8 (following titration from 0.25 mg to 1 mg).


Pomalidomide

Generic Name
POMALIDOMIDE
Trade Name
POMALYST
Projected Completion Date
31-Dec-27
Study Status
Pending

Description of Commitment

Submit the final report from a clinical trial evaluating overall response rate, duration of response, and safety to verify and describe the clinical benefit of pomalidomide in patients with Kaposi sarcoma who are human immunodeficiency virus (HIV) positive (after failure of highly active antiretroviral therapy) and HIV negative, that may inform product labeling.


Romidepsin

Generic Name
ROMIDEPSIN
Trade Name
ISTODAX
Projected Completion Date
30-Apr-19
Study Status
Delayed

Description of Commitment

To perform a randomized, blinded, controlled trial of previously untreated PTCL patients randomized to treatment with CHOP or to romidepsin plus CHOP, with Progression Free Survival as the primary efficacy endpoint. Final Progression Free Survival (PFS) data will be available at Trial Completion. For efficacy, the final analysis of the primary endpoint, PFS, will be performed when the trial has experienced the planned number of events. Using the same data cutoff date, an interim analysis of Overall Survival will be performed and included in the study report.

Explanatory Note

FDA acknowledged revised trial completion and final report submission milestone due dates based on lower than expected PFS event rates.     

Generic Name
ROMIDEPSIN
Trade Name
ISTODAX
Projected Completion Date
31-Dec-21
Study Status
Pending

Description of Commitment

Submit the hypothesis for the final Overall Survival (OS) analysis from the required Clinical Trial (PMR), and the final OS analysis will be performed in accordance with the OS plan. The Study Completion refers to the Statistical Analysis Plan for the required Clinical PMR, it will be April 2021.

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