MERCK SHARP DOHME — Keytruda FDA Summary Review (NDA/BLA 125514, 2020)
Merck & Co., Inc. · 2020 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
Merck sought approval for a new 400 mg every six weeks (Q6W) dosing regimen for Keytruda across all approved indications. Initially, the FDA issued a Complete Response letter due to concerns about pharmacokinetic bridging and potential efficacy reduction. Merck submitted additional data, including from Study KN555, addressing these concerns. The FDA subsequently granted Accelerated Approval for the 400 mg Q6W regimen, based on pharmacokinetic modeling and observed data indicating comparable efficacy and safety to the existing 200 mg Q3W regimen. This extended dosing offers public health benefits by reducing patient visits. The approval is contingent on ongoing confirmatory trials.
Key findings — cited to the page
| Grade 3 to 5 AEs for pembrolizumab 10 mg/kg Q2W in rrCHD | 42% | KN013- cohort 3 · p.13 |
| IMaRs / IRRs G3 to 5 in Reference Safety Database | 6% | · p.13 |
| Grade 3 to 5 AEs for pembrolizumab 2 mg/kg Q3W | 47% | KN001, 002, 006, 010 · p.12 |
| Grade 3 to 5 AEs for pembrolizumab 200 mg Q3W in rrCHD | 33% | KN087 · p.13 |
| IMaRs / IRRs G3 to 5 for pembrolizumab 200 mg Q3W in rrCHD | 4% | KN087 · p.13 |
| IMaRs / IRRs G3 to 5 for pembrolizumab 10 mg/kg Q2W in rrCHD | 10% | KN013- cohort 3 · p.13 |
| Grade 3 to 5 AEs for pembrolizumab 400 mg Q6W | 25% | KN555 · p.10 |
| IMaRs or IRRs for pembrolizumab 400 mg Q6W | 15.9% | KN555 · p.10 |
| Grade 3 to 5 AEs for pembrolizumab 10 mg/kg Q3W | 47% | KN001, 002, 006, 010 · p.12 |
| Grade 3 to 5 AEs for pembrolizumab 10 mg/kg Q2W | 46% | KN001, 002, 006, 010 · p.12 |
| Grade 3 to 5 AEs in Reference Safety Database | 46% | · p.13 |
| Discontinued for IMaR / IRR for pembrolizumab 200 mg Q3W in rrCHD | 7% | KN087 · p.13 |
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 →