MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2019)
Merck & Co., Inc. · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA review details the approval of Merck's Keytruda (pembrolizumab) for various cancers, including melanoma, NSCLC, HNSCC, cHL, urothelial carcinoma, and MSI-H/dMMR cancers, many under accelerated approval. The report comprehensively covers its efficacy, safety profile, and clinical pharmacology based on numerous KEYNOTE trials. Keytruda demonstrated significant objective response rates and improved survival across indications, with a consistent safety profile. The review also addresses postmarketing requirements, regulatory history, and the rationale for its "tissue-agnostic" approval for MSI-H/dMMR tumors, emphasizing the unmet medical need and the predictive value of MSI-H status.
Key findings — cited to the page
| Grade 5 Pneumonitis incidence | 0.1 % | KEYTRUDA · p.20 |
| Grade 3 Hepatitis incidence | 0.4 % | KEYTRUDA · p.20 |
| Grade 1 Pneumonitis incidence | 0.8 % | KEYTRUDA · p.20 |
| Grade 4 Pneumonitis incidence | 0.3 % | KEYTRUDA · p.20 |
| Grade 2 Colitis incidence | 0.4 % | KEYTRUDA · p.20 |
| Grade 2 Hepatitis incidence | 0.1 % | KEYTRUDA · p.20 |
| Grade 3-4 Vitiligo incidence (KEYNOTE-006, Ipilimumab arm) | 0 % | Ipilimumab · p.24 |
| Grade 4 Colitis incidence | <0.1 % | KEYTRUDA · p.20 |
| Grade 2 Pneumonitis incidence | 1.3 % | KEYTRUDA · p.20 |
| Grade 3 Pneumonitis incidence | 0.9 % | KEYTRUDA · p.20 |
| Grade 3 Colitis incidence | 1.1 % | KEYTRUDA · p.20 |
| Grade 4 Hepatitis incidence | <0.1 % | KEYTRUDA · p.20 |
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 →