MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2023)
Merck & Co., Inc. · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package, dated June 10, 2019, details the approval of Merck Sharp & Dohme's KEYTRUDA (pembrolizumab) for numerous cancer indications, including melanoma, NSCLC, HNSCC, and others. It outlines approved dosages, dose modification guidelines for immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis), and incidence rates of these events. The report extensively covers KEYTRUDA's efficacy and safety profile across various clinical trials (e.g., KEYNOTE-006, -054, -189, -407, -048). Efficacy results demonstrate significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rates (ORR) in many cancer types, often in combination with chemotherapy or as monotherapy, particularly in PD-L1 positive populations. Safety data highlights immune-mediated adverse reactions, infusion-related reactions, and laboratory abnormalities. The KEYNOTE-048 trial for HNSCC is a major focus, showing OS benefits for KEYTRUDA with or without chemotherapy, leading to its regular approval for first-line treatment. The document also addresses regulatory requirements, including postmarketing commitments and pediatric study plans.
Key findings — cited to the page
| Pneumonitis incidence (Grade 5) in HNSCC (combination with platinum and FU) | 0.4 % | KEYTRUDA · p.23 |
| Pneumonitis incidence (Grade 3) in HNSCC (combination with platinum and FU) | 1.1 % | KEYTRUDA · p.23 |
| Pneumonitis incidence (Grade 3) in HNSCC (single agent) | 1.3 % | KEYTRUDA · p.23 |
| Pneumonitis incidence (Grade 5) in HNSCC (single agent) | 0.3 % | KEYTRUDA · p.23 |
| Pneumonitis incidence (Grade 4) | 0.3 % | KEYTRUDA · p.22 |
| Pneumonitis incidence (Grades 3-4) in NSCLC (single agent, first-line) | 3.2 % | KEYTRUDA · p.22 |
| Pneumonitis incidence (Grade 5) | 0.1 % | KEYTRUDA · p.22 |
| Pneumonitis incidence (Grade 2) | 1.3 % | KEYTRUDA · p.22 |
| Pneumonitis incidence (Grade 1) | 0.8 % | KEYTRUDA · p.22 |
| Pneumonitis incidence (all grades) | 3.4 % | KEYTRUDA · p.22 |
| Pneumonitis incidence (Grade 3) | 0.9 % | KEYTRUDA · p.22 |
| Colitis incidence (all grades) | 1.7 % | KEYTRUDA · p.23 |
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 →