Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2023)
Merck & Co., Inc. · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
Merck's Keytruda (pembrolizumab) received FDA approval on June 12, 2018, for numerous cancer indications, including melanoma, NSCLC, HNSCC, cHL, urothelial carcinoma, MSI-H cancer, gastric cancer, and cervical cancer. Many approvals were accelerated, contingent on confirmatory trials. The report details recommended dosages, dose modifications, and extensive safety profiles across various cancer types, including immune-mediated adverse reactions and common adverse events, both as monotherapy and in combination. Clinical pharmacology and efficacy data from multiple KEYNOTE studies highlight overall survival, progression-free survival, and objective response rates. Specifically for cervical cancer, the KEYNOTE-158 trial supported accelerated approval based on objective response rates and duration of response in PD-L1 positive patients. Post-marketing commitments include further clinical trials and biomarker evaluations.
Key findings — cited to the page
| All Grades Dyspnea | 39 % | KEYNOTE-021 · p.30 |
| Grade 3-4 Hyponatremia | 5 % | KEYNOTE-021 · p.31 |
| All Grades Rash | 17 % | KEYNOTE-010 · p.28 |
| Grade 3-4 Pruritus | 0 % | KEYNOTE-010 · p.28 |
| All Grades Cough | 24 % | KEYNOTE-021 · p.30 |
| All Grades Hyponatremia | 33 % | KEYNOTE-021 · p.31 |
| Grade 3-4 Cough | 0 % | KEYNOTE-021 · p.30 |
| Grades 3-4 Glucose increased | 8 % | KEYNOTE-045 · p.37 |
| Grade 3-4 Rash | 0.4 % | KEYNOTE-010 · p.28 |
| All Grades Pruritus | 11 % | KEYNOTE-010 · p.28 |
| Grade 3-4 Dyspnea | 3.4 % | KEYNOTE-021 · p.30 |
| All Grades Pyrexia | 11 % | KEYNOTE-052 · p.34 |
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 →