MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023)
Merck & Co., Inc. · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA review details the approval package for Merck's Keytruda (pembrolizumab), approved July 30, 2019, with numerous indications across various cancer types, including accelerated approvals based on tumor response. It outlines recommended dosages and extensive guidelines for managing immune-mediated adverse reactions, infusion reactions, and complications with allogeneic HSCT. The report highlights Keytruda's safety profile, noting increased mortality in multiple myeloma patients when combined with thalidomide analogue and dexamethasone. Efficacy data from trials like KEYNOTE-006, -002, -054, -189, -407, -042, -024, -010, -028, -158, -048, -224, -017, -426, -180, and -181 demonstrate improvements in overall survival, progression-free survival, and objective response rates across melanoma, NSCLC, SCLC, HNSCC, cHL, PMBCL, Urothelial Carcinoma, MSI-H Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, and Renal Cell Carcinoma, often compared to chemotherapy or other standard treatments. The review also covers the specific traditional approval for esophageal cancer based on KEYNOTE-180 and -181.
Key findings — cited to the page
| Pneumonitis incidence (Grade 2) | 1.3 % | KEYTRUDA as single agent · p.22 |
| Pneumonitis incidence (Grade 5) | 0.1 % | KEYTRUDA as single agent · p.22 |
| Rash (All Grades) | 17 % | KEYNOTE-010 · p.36 |
| Pneumonitis incidence (Grade 1) | 0.8 % | KEYTRUDA as single agent · p.22 |
| Pneumonitis incidence (Grade 3) | 0.9 % | KEYTRUDA as single agent · p.22 |
| Pneumonitis incidence (Grade 4) | 0.3 % | KEYTRUDA as single agent · p.22 |
| Rash (All Grades) | 20 % | KEYNOTE-087 · p.40 |
| Hyperglycemia (Grades 3-4) | 4.7 % | KEYNOTE-042 · p.35 |
| Pneumonitis incidence (all grades) | 6 % | KEYTRUDA as single agent for HNSCC (KEYNOTE-048) · p.22 |
| Pneumonitis incidence (all grades) | 3.4 % | KEYTRUDA as single agent · p.22 |
| Rash (Grades 3-4) | 0.4 % | KEYNOTE-010 · p.36 |
| Pneumonitis incidence (all grades) | 8.2 % | KEYTRUDA as single agent for NSCLC · p.22 |
Source: Merck & Co., Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →