MERCK SHARP DOHME — Keytruda FDA Review (NDA/BLA 125514, 2022)
Merck & Co., Inc. · 2022 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Merck Sharp & Dohme's Keytruda (pembrolizumab), approved April 11, 2019, for numerous cancer indications. It outlines dosage, administration, and warnings regarding immune-mediated adverse reactions. Comprehensive safety and efficacy data from various KEYNOTE trials across diverse cancer types (melanoma, NSCLC, cHL, PMBCL, urothelial, gastric, cervical, HCC, MCC, MSI-H/dMMR) are presented. The report highlights Keytruda's safety profile, including adverse events and laboratory abnormalities, and its efficacy in improving overall survival, progression-free survival, and objective response rates compared to chemotherapy or ipilimumab. Specifically, the KEYNOTE-042 trial demonstrated significant overall survival benefits for Keytruda as a first-line monotherapy in PD-L1 positive advanced NSCLC, with an acceptable safety profile despite increased immune-mediated adverse events.
Key findings — cited to the page
| grade 3-5 AEs | 57 % | KEYNOTE-042 · p.165 |
| most common Grade 3-5 AEs: infections and infestations | 12 % | KEYNOTE-042 · p.172 |
| Percentage of ITT population with disease upgraded from Stage III to Stage IV | 0.9 % | KEYNOTE-042 · p.139 |
| grade 3-5 AEs | 50 % | KEYNOTE-042 · p.165 |
| incidence of Grade 3-5 AEs | 50 % | KEYNOTE-042 · p.172 |
| most common Grade 3-5 AEs: respiratory, thoracic and mediastinal disorders | 14 % | KEYNOTE-042 · p.172 |
| Number of Stage III patients whose disease was upgraded to Stage IV after enrollment | 11 patients | KEYNOTE-042 · p.138 |
| Percentage of Stage III patients whose disease was upgraded to Stage IV after enrollment | 7 % | KEYNOTE-042 · p.139 |
| incidence of grade 3-5 AEs | 57 % | KEYNOTE-042 · p.164 |
| incidence of grade 3-5 AEs | 50 % | KEYNOTE-042 · p.164 |
| incidence of Grade 3-5 AEs | 57 % | KEYNOTE-042 · p.172 |
| most common Grade 3-5 AEs: blood and lymphatic system disorders | 24 % | KEYNOTE-042 · p.172 |
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 →