Amgen Inc. — Lumakras FDA Review (NDA/BLA 214665, 2025)
Amgen Inc. · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
Amgen's Lumakras (sotorasib) received FDA approval on January 16, 2025, for KRAS G12C-mutated NSCLC (accelerated approval) and in combination with panitumumab for KRAS G12C-mutated metastatic colorectal cancer (mCRC). The report details dosage, administration, and warnings for hepatotoxicity and ILD/pneumonitis. Efficacy and safety data, primarily from the pivotal Phase 3 CodeBreaK 300 trial (Study 20190172), support the mCRC indication, showing improved progression-free survival and higher response rates with sotorasib plus panitumumab compared to standard of care. The safety profile is consistent with individual drugs, with common adverse events and specific concerns like intestinal obstruction. Despite some data quality issues and fraud at one clinical site, the FDA concluded the benefit-risk profile supports traditional approval for mCRC.
Key findings — cited to the page
| Increased ALT or AST (Grade 3) in mCRC combination therapy | 0.8 % | LUMAKRAS (sotorasib) in combination with panitumumab · p.16 |
| Hyperbilirubinemia (all grades) in mCRC combination therapy | 3.2 % | LUMAKRAS (sotorasib) in combination with panitumumab · p.16 |
| Increased ALT/AST (all grades) | 17 % | LUMAKRAS (sotorasib) · p.15 |
| Increased ALT or AST (all grades) in mCRC combination therapy | 7 % | LUMAKRAS (sotorasib) in combination with panitumumab · p.16 |
| Hepatotoxicity (all grades) in mCRC combination therapy | 15 % | LUMAKRAS (sotorasib) in combination with panitumumab · p.16 |
| Drug-induced liver injury (Grade ≥ 3) | 1.3 % | LUMAKRAS (sotorasib) · p.15 |
| Hepatotoxicity (all grades) | 27 % | LUMAKRAS (sotorasib) · p.15 |
| Hepatotoxicity (Grade ≥ 3) | 16 % | LUMAKRAS (sotorasib) · p.15 |
| Increased ALT/AST (Grade ≥ 3) | 9 % | LUMAKRAS (sotorasib) · p.15 |
| Hepatotoxicity (Grade 3) in mCRC combination therapy | 4.8 % | LUMAKRAS (sotorasib) in combination with panitumumab · p.16 |
| Drug-induced liver injury (all grades) | 1.6 % | LUMAKRAS (sotorasib) · p.15 |
| Hyperbilirubinemia (Grade 3) in mCRC combination therapy | 2.4 % | LUMAKRAS (sotorasib) in combination with panitumumab · p.16 |
Source: Amgen 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 →