Bristol-Myers Squibb Company — Krazati EMA EPAR public assessment report (EMEA/H/C/006013, 2024)
Bristol-Myers Squibb Company · 2024 · EMA EPAR public assessment report · company profile →
Report summary
Krazati (adagrasib) received conditional marketing authorization in the EU for advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation after prior systemic therapy. The drug, developed by Mirati Therapeutics B.V., targets an unmet medical need. Preclinical and clinical studies, primarily the KRYSTAL-1 trial, demonstrated its potent activity against KRAS G12C, showing an objective response rate of 41.4%, median duration of response of 8.5 months, and median progression-free survival of 6.0 months. While safety concerns included gastrointestinal toxicities and other adverse events, most were manageable. The CHMP, following re-examination, concluded a favorable benefit-risk balance, despite some dissenting opinions regarding long-term benefits and comparison to existing therapies.
Key findings — cited to the page
| median time to Grade 3 electrocardiogram prolonged | 8.0 days | · p.122 |
| maximum QTcF on-study Grade 3 severity | 13.0 % | · p.122 |
| Grade 3 electrocardiogram QT prolonged incidence | 5.9 % | · p.122 |
| Grade >=3 nausea (nausea, vomiting, retching) | 4.8 % | KRYSTAL-1 (All NSCLC 600 mg BID group) · p.120 |
| Grade 0 QTcF prolongation at baseline | 93.5 % | · p.121 |
| Grade 1 QTcF prolongation at baseline | 6.5 % | · p.121 |
| patients with any Grade 3 or Greater TEAEs | 95 | KRYSTAL-1 (Cohort A) · p.110 |
| Grade >=3 diarrhoea | 4.3 % | KRYSTAL-1 (All NSCLC 600 mg BID group) · p.120 |
| patients with any Grade 3 or Greater MRTX849-related TEAE | 52 | KRYSTAL-1 (Cohort A) · p.110 |
| high-grade (≥G3) anaemia incidence in NSCLC pool | 11.7 % | · p.136 |
| liver disorders (pooled preferred terms) grade ≥3 incidence | 9 % | · p.121 |
| median duration of Grade 3 electrocardiogram prolonged events | 4 days | · p.122 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →