Bristol-Myers Squibb Company — Krazati FDA Review (NDA216340, ORIG 1, 2022)
Bristol-Myers Squibb Company · 2022 · FDA Review (openFDA) · company profile →
Report summary
The FDA granted Accelerated Approval for Krazati (adagrasib) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, who have received at least one prior systemic therapy. This decision was based on the single-arm KRYSTAL-1 trial, which demonstrated a 43% objective response rate and a median duration of response of 8.5 months. While Krazati addresses an unmet medical need, the review highlighted a high toxicity profile, with 79% of patients experiencing Grade 3 or higher adverse events and 82% requiring dose modifications. Consequently, a postmarketing requirement for dose optimization studies was issued. Preclinical and clinical pharmacology studies supported the mechanism of action and identified potential toxicities, including cardiac and respiratory effects. The FDA also mandated a randomized Phase 3 trial against docetaxel and further drug-drug interaction studies.
Key findings — cited to the page
| treatment emergent laboratory abnormalities (any grade) | 19 % | primary safety population · p.177 |
| Gastrointestinal adverse reactions (any grade) | 89% | Krazati (adagrasib) · p.20 |
| treatment emergent laboratory abnormalities (any grade) | 35 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 20 % | primary safety population · p.177 |
| Grade ≥3 hematologic laboratory abnormalities | 25 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 16 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 46 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 41 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 27 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 26 % | primary safety population · p.177 |
| treatment emergent laboratory abnormalities (any grade) | 17 % | primary safety population · p.177 |
| Gastrointestinal adverse reactions (Grade 3) | 9% | Krazati (adagrasib) · p.20 |
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 →