Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026)
Merck & Co., Inc. · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
Merck's Keytruda (pembrolizumab) received FDA approval on March 19, 2025, for first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma with PD-L1 (CPS>1). This approval, based on the KEYNOTE-811 trial, demonstrated significant improvements in overall survival, progression-free survival, and objective response rate when Keytruda is combined with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy. The report details Keytruda's extensive efficacy across numerous cancer types, both as a monotherapy and in combination regimens, including melanoma, NSCLC, HNSCC, urothelial carcinoma, and TNBC. It also provides comprehensive safety information, outlining immune-mediated adverse reactions, their management, and the drug's safety profile in various populations and combination therapies, confirming no new safety signals were identified in the gastric cancer indication.
Key findings — cited to the page
| Grade 4 immune-mediated colitis | <0.1 % | KEYTRUDA · p.21 |
| Grade 3 immune-mediated hepatitis (single agent) | 0.4 % | KEYTRUDA · p.21 |
| Grade 2 immune-mediated pneumonitis | 1.3 % | KEYTRUDA · p.21 |
| Grade 3 pneumonitis in resected NSCLC patients (KEYNOTE-091) | 1 % | KEYTRUDA · p.21 |
| Grade 2 immune-mediated colitis | 0.4 % | KEYTRUDA · p.21 |
| Grade 4 immune-mediated hepatitis (single agent) | <0.1 % | KEYTRUDA · p.21 |
| Grade 4 immune-mediated pneumonitis | 0.3 % | KEYTRUDA · p.21 |
| Grade 3 immune-mediated pneumonitis | 0.9 % | KEYTRUDA · p.21 |
| Grade 3-4 pneumonitis in cHL patients | 2.3 % | KEYTRUDA · p.21 |
| Grade 4 pneumonitis in resected NSCLC patients (KEYNOTE-091) | 0.3 % | KEYTRUDA · p.21 |
| Grade 3 immune-mediated colitis | 1.1 % | KEYTRUDA · p.21 |
| Grade 2 immune-mediated hepatitis (single agent) | 0.1 % | KEYTRUDA · p.21 |
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 →