Drug Safety Information for KEYTRUDA ()
FDA Safety-related Labeling Changes for KEYTRUDA (PEMBROLIZUMAB) Biological Drug: Safety Information Link
Required post-approval safety study:
Characterize the safety of long-term use in patients with classical Hodgkin lymphoma treated with pembrolizumab 200 mg every 3 weeks. Submit a final report and datasets with safety and efficacy outcomes of trial KN087 with at least 3 years of follow-up data. Due Date: 2021-08-31
Required post-approval safety study:
Characterize the long-term safety of pembrolizumab 2 mg/kg every 3 weeks, in pre-pubertal pediatric patients and those who have not completed pubertal development. Submit a report and datasets that include long-term follow-up of patients enrolled on KN051, a Phase I/II Study of Pembrolizumab (MK-3475) in children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma. Enroll at least 20 patients, including at least 5 patients who are pre-pubertal and 10 who have not yet completed pubertal development. For any pre-pubertal patients and those who have not completed pubertal development, perform the following actions: include in the safety evaluation, immune-mediated, endocrine, and reproductive toxicities for subjects with at least 5 years of follow-up or until pubertal development is complete, whichever is longer. Due Date: 2027-04-30
Required post-approval safety study:
Conduct clinical trial KEYNOTE-826 (KN-826) in cervical cancer for Progression Free Survival (PFS)-Overall Survival (OS), entitled ""A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy vs. Chemotherapy Plus Placebo for the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer"". Submit analyses and datasets with final report for PFS and OS. Due Date: 2023-05-31
Required post-approval safety study:
Complete the trial and submit the final report and data to verify and describe the clinical benefit of pembrolizumab, including efficacy and safety, from Trial KN204, a Phase 3 randomized, open-label, active-controlled trial comparing pembrolizumab to brentuximab vedotin for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma. Enroll approximately 300 patients. The primary endpoint should include progression-free survival. Due Date: 2021-04-30
Required post-approval safety study:
Submit the median Duration of Response (DOR) analyses and datasets with the final report of clinical trial Keynote 158 (Cohort E), entitled ""A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors Due Date: 2020-02-28
Required post-approval safety study:
Characterize the safety of long-term use in patients with primary mediastinal large B-cell lymphoma. Submit a final report and data sets with safety and efficacy outcomes of trial KEYNOTE-170 with at least 3 years of follow-up data. Due Date: 2020-11-30
Required post-approval safety study:
Characterize complications after allogeneic hematopoietic stem cell transplantation (HSCT) following pembrolizumab in at least 90 patients with hematologic malignancies, of which at least 30% had received pembrolizumab alone or in combination as the regimen immediately prior to the allogeneic HSCT conditioning regimen. Evaluate toxicities at least through transplant Day 180. Include details of prior pembrolizumab treatment and the transplant regimen. Characterize toxicities including hyperacute graft-versus-host disease (GVHD), severe (grade 3-4) acute GVHD, febrile syndromes treated with steroids, immune mediated adverse events, pulmonary complications, hepatic veno-occlusive disease and/or sinusoidal obstruction syndrome, critical illness, and transplantrelated mortality. Toxicities may be characterized prospectively, or through a combination of prospective and retrospective data analysis. Due Date: 2024-12-31
Required post-approval safety study:
Conduct clinical trial KEYNOTE-361 entitled ""A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma"". Submit the datasets with the final report. Due Date: 2021-11-30
Required post-approval safety study:
Conduct a trial that will characterize the safety of pembrolizumab administered intravenously at 2 mg/kg up to a maximum of 200 mg intravenously every three weeks or to determine a reasonably safe dosage regimen in an adequate number of children with primary central nervous system malignancies that are mismatch repair deficient or microsatellite instability high. Submit a final report and datasets for pediatric patients with primary CNS malignancies. Due Date: 2023-03-31
Required post-approval safety study:
Submit the final report, including datasets, from trials conducted to verify and describe the clinical benefit of pembrolizumab 200 mg intravenously every three weeks in patients with microsatellite instability high or mismatch repair deficient tumors including at least 124 patients with colorectal cancer enrolled in Merckinitiated trials at least 300 patients with non-colorectal cancer, including a sufficient number of patients with prostate cancer, thyroid cancer, small cell lung cancer and ovarian cancer and 25 children. In order to characterize response rate and duration, patients will be followed for at least 12 months from the onset of response. Due Date: 2023-03-31
Required post-approval safety study:
Complete the trial and submit the final report and data to verify and describe the clinical benefit of pembrolizumab, including efficacy and safety, from Trial KN204, a Phase 3 randomized, open-label, active-controlled trial comparing pembrolizumab to brentuximab vedotin for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma. Enroll approximately 300 patients. The primary endpoint should include progression-free survival. Due Date: 2021-04-30
Original FDA Drug Approval Date for KEYTRUDA: 2014-09-04
FDA Adverse Event Summary for KEYTRUDA (not avail) Unavailable