MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2021)
Merck & Co., Inc. · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA review details Keytruda's (pembrolizumab) approval for numerous cancer indications, including melanoma, NSCLC, head and neck squamous cell cancer, Hodgkin lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, hepatocellular carcinoma, and Merkel cell carcinoma. Many approvals, particularly for MCC, were accelerated based on trials like KEYNOTE-017, showing significant objective response rates and duration of response. The report outlines extensive efficacy data from various KEYNOTE trials, demonstrating improved overall survival, progression-free survival, and objective response rates across different cancer types. Comprehensive safety information is provided, detailing immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis), their incidence, severity, and management. Dosage, administration, pharmacokinetics, and use in specific populations are also covered.
Key findings — cited to the page
| Grade 1 pneumonitis incidence | 0.8 % | KEYTRUDA · p.20 |
| Grade 2 pneumonitis incidence | 1.3 % | KEYTRUDA · p.20 |
| Grade 3 hypophysitis incidence | 0.3 % | KEYTRUDA · p.21 |
| Fatigue (All Grades) | 38 % | KEYNOTE-052 · p.39 |
| Nausea (Grade 3-4) | 0 % | KEYNOTE-170 · p.37 |
| Grade 2 hypophysitis incidence | 0.2 % | KEYTRUDA · p.21 |
| Diarrhea (All Grades) | 13 % | KEYNOTE-170 · p.37 |
| Diarrhea (Grade 3-4) | 2 % | KEYNOTE-170 · p.37 |
| Abdominal pain (All Grades) | 13 % | KEYNOTE-170 · p.37 |
| Abdominal pain (Grade 3-4) | 0 % | KEYNOTE-170 · p.37 |
| Nausea (All Grades) | 11 % | KEYNOTE-170 · p.37 |
| Grade 3 pneumonitis incidence | 0.9 % | 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 →