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 June 12, 2025, for resectable locally advanced HNSCC with PD-L1 expression (CPS≥1), based on the KEYNOTE-689 trial. This approval, under BLA 125514, includes a postmarketing commitment for long-term efficacy data. The report details Keytruda's extensive indications and dosages across various cancers, including melanoma, NSCLC, and HNSCC. Safety profiles highlight immune-mediated adverse reactions, with incidence rates and management strategies. Efficacy data from numerous KEYNOTE trials consistently demonstrate improved overall survival, progression-free survival, and objective response rates for Keytruda as monotherapy or in combination, compared to standard treatments, across diverse cancer types and patient populations. The FDA generally concurred with Merck's safety and efficacy assessments, noting no new safety concerns but higher adverse event rates in some subgroups.
Key findings — cited to the page
| Hypercholesterolemia (Grades 3-4) | 0.7 % | KEYNOTE-010 · p.36 |
| Grade 4 immune-mediated pneumonitis incidence | 0.3 % | · p.22 |
| Grade 3-4 Neutropenia | 7 % | KEYNOTE-087 · p.49 |
| Hypercholesterolemia (all grades) | 20 % | KEYNOTE-010 · p.36 |
| Increased creatinine (Grades 3-4) | 3.3 % | KEYNOTE-869 · p.55 |
| Anemia (All Grades) | 69 % | KEYNOTE-869 · p.55 |
| Lymphopenia (Grades 3-4) | 9 % | KEYNOTE-010 · p.36 |
| Hypoalbuminemia (all grades) | 34 % | KEYNOTE-010 · p.36 |
| Hypoalbuminemia (Grades 3-4) | 1.6 % | KEYNOTE-010 · p.36 |
| Lymphopenia (All Grades) | 64 % | KEYNOTE-869 · p.55 |
| Lymphopenia (Grades 3-4) | 17 % | KEYNOTE-869 · p.55 |
| Grade 3 immune-mediated pneumonitis incidence | 0.9 % | · 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 →