Merck & Co., Inc. — Keytruda FDA Review (NDA/BLA 125514, 2023)
Merck & Co., Inc. · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Merck's Keytruda (pembrolizumab) on August 5, 2016, for unresectable/metastatic melanoma, metastatic NSCLC, and recurrent/metastatic HNSCC, all under accelerated approval. Efficacy in HNSCC was based on objective response rates (16.1-18%) and durable responses from KEYNOTE-012 and KEYNOTE-055 trials, with a confirmatory trial (KEYNOTE-040) underway. The safety profile, consistent across indications, highlights immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies) and infusion-related reactions. While generally acceptable, HNSCC patients showed increased facial edema and hypothyroidism. The report details trial designs, subgroup analyses, and post-marketing requirements.
Key findings — cited to the page
| Pneumonitis incidence (Grade 3) in NSCLC | 1.3 % | KEYTRUDA (pembrolizumab) · p.14 |
| Colitis incidence (all grades) | 2.0 % | KEYTRUDA (pembrolizumab) · p.15 |
| Pneumonitis incidence (Grade 2) | 0.8 % | KEYTRUDA (pembrolizumab) · p.14 |
| Pneumonitis incidence (Grade 2) in NSCLC | 1.1 % | KEYTRUDA (pembrolizumab) · p.14 |
| Hepatitis incidence (Grade 2) | 0.1 % | KEYTRUDA (pembrolizumab) · p.16 |
| Pneumonitis incidence (Grade 5) in NSCLC | 0.2 % | KEYTRUDA (pembrolizumab) · p.14 |
| Pneumonitis incidence (all grades) | 2.0 % | KEYTRUDA (pembrolizumab) · p.14 |
| Pneumonitis incidence (Grade 1) | 0.8 % | KEYTRUDA (pembrolizumab) · p.14 |
| Pneumonitis incidence (Grade 3) | 0.4 % | KEYTRUDA (pembrolizumab) · p.14 |
| Pneumonitis incidence (all grades) in NSCLC | 3.5 % | KEYTRUDA (pembrolizumab) · p.14 |
| Pneumonitis incidence (Grade 4) in NSCLC | 0.4 % | KEYTRUDA (pembrolizumab) · p.14 |
| Colitis incidence (Grade 2) | 0.5 % | KEYTRUDA (pembrolizumab) · p.15 |
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 →