Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2024)
Merck & Co., Inc. · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
Merck's Keytruda (pembrolizumab) has received FDA approval for numerous cancer indications, including melanoma, NSCLC, HNSCC, cHL, and various other solid tumors, often with an additional 400 mg every 6 weeks dosing regimen. Approvals include both traditional and accelerated pathways, with efficacy demonstrated through improved overall survival, progression-free survival, and objective response rates in trials like KEYNOTE-006, KEYNOTE-407, and KEYNOTE-811. The safety profile, consistently reviewed across monotherapy and combination regimens, highlights immune-mediated adverse reactions such as pneumonitis and colitis, along with common adverse events. The FDA has deemed the safety profile manageable, with no new concerns identified in combination therapies. Post-marketing requirements are in place for ongoing efficacy and safety confirmation.
Key findings — cited to the page
| Grade 4 hepatitis incidence (Keytruda as single agent) | <0.1 % | KEYTRUDA · p.25 |
| Grade 2 hepatitis incidence (Keytruda as single agent) | 0.1 % | KEYTRUDA · p.25 |
| Grade 3-4 pneumonitis incidence in cHL patients | 2.3 % | KEYTRUDA · p.25 |
| Grade 2 colitis incidence | 0.4 % | KEYTRUDA · p.25 |
| Grade 3 hepatitis incidence (Keytruda as single agent) | 0.4 % | KEYTRUDA · p.25 |
| Nausea (Grades 3-4) in Placebo arm | 7 % | KEYNOTE-590 · p.53 |
| Grade 3 pneumonitis incidence | 0.9 % | KEYTRUDA · p.24 |
| Grade 2 pneumonitis incidence | 1.3 % | KEYTRUDA · p.24 |
| Grade 4 colitis incidence | <0.1 % | KEYTRUDA · p.25 |
| Grade 3 colitis incidence | 1.1 % | KEYTRUDA · p.25 |
| Grade 4 pneumonitis incidence | 0.3 % | KEYTRUDA · p.24 |
| Grade 3 increased ALT incidence (Keytruda with axitinib) | 20 % | KEYTRUDA · p.25 |
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 →