Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2026)
Merck & Co., Inc. · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Keytruda's (pembrolizumab) approval on May 12, 2026, for numerous cancer indications, including melanoma, NSCLC, various lymphomas, and MSI-H/dMMR cancers. The document outlines comprehensive safety profiles, adverse reactions (including immune-mediated events like Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome), and dosage modifications for monotherapy and combination regimens. Efficacy data consistently demonstrate significant improvements in overall survival, progression-free survival, and objective response rates across diverse cancer types and treatment settings, often compared to chemotherapy or placebo. The report also covers pediatric/geriatric use and pharmacokinetic properties.
Key findings — cited to the page
| Constipation (All Grades) | 22 % | KEYNOTE-002 · p.35 |
| Diarrhea (Grades 3-4) | 0.8 % | KEYNOTE-002 · p.35 |
| Pruritus (All Grades) | 28 % | KEYNOTE-002 · p.35 |
| Rash (Grades 3-4) | 0.6 % | KEYNOTE-002 · p.35 |
| Constipation (Grades 3-4) | 0.3 % | KEYNOTE-002 · p.35 |
| Diarrhea (All Grades) | 20 % | KEYNOTE-002 · p.35 |
| Neutropenia (All Grades) | 50 % | KEYNOTE-189 · p.39 |
| Neutropenia (Grades 3-4) | 21 % | KEYNOTE-189 · p.39 |
| Pruritus (Grades 3-4) | 0 % | KEYNOTE-002 · p.35 |
| Rash (All Grades) | 24 % | KEYNOTE-002 · p.35 |
| Cough (All Grades) | 21 % | KEYNOTE-189 · p.38 |
| Abdominal pain (All Grades) | 13 % | KEYNOTE-002 · p.35 |
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 →