Bristol-Myers Squibb Company — Krazati FDA Review (NDA/BLA 216340, 2024)
Bristol-Myers Squibb Company · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
Krazati (adagrasib) received accelerated FDA approval on June 21, 2024, for KRAS G12C-mutated locally advanced or metastatic colorectal cancer in combination with cetuximab, following prior chemotherapy. This approval, contingent on confirmatory trials, recommends a 600 mg oral dosage twice daily. The multi-disciplinary review highlighted efficacy from the KRYSTAL-1 study, showing a 34% objective response rate and 5.8-month median duration of response in CRC patients. The safety profile, detailed across various trials, identified common adverse events like diarrhea and nausea, and specific toxicities including QTc prolongation. The review also addressed the need for a companion diagnostic and the unmet need for targeted therapies in this patient population.
Key findings — cited to the page
| Grade 4 increased ALT/AST (KRAZATI + cetuximab) | 1.1 % | KRAZATI · p.17 |
| grade 3-4 adverse events (Adagrasib 400 mg BID + cetuximab) | 48% | · p.54 |
| Grade 4 increased ALT/AST (single-agent KRAZATI) | 0.5 % | KRAZATI · p.17 |
| Grade 3 increased ALT/AST (KRAZATI + cetuximab) | 5 % | KRAZATI · p.17 |
| grade 3-4 adverse events (adagrasib 600 mg BID + cetuximab) | 62% | · p.57 |
| grade 3-4 adverse events (dose optimization cohort, adagrasib 400 mg BID + cetuximab) | 48% | · p.57 |
| Grade 3 gastrointestinal adverse reactions (single-agent KRAZATI) | 9 % | KRAZATI · p.16 |
| Grade 3 increased ALT/AST (single-agent KRAZATI) | 5 % | KRAZATI · p.17 |
| Grade 3 gastrointestinal adverse reactions (KRAZATI + cetuximab) | 6 % | KRAZATI · p.16 |
| Grade 3 or 4 hepatotoxicity (single-agent KRAZATI) | 7 % | KRAZATI · p.17 |
| Grade 3 or 4 decreased lymphocytes (pooled safety population) | 20 % | · p.19 |
| Grade 3 or 4 ILD/pneumonitis (single-agent KRAZATI) | 1.4 % | · p.18 |
Source: Bristol-Myers Squibb Company ↗ · 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 →