Lumakras(sotorasib)
Oncology· 2434 cited findings· 2 source documents
Company: Amgen Inc. →
What the regulatory reviews say
LUMAKRAS (sotorasib, code name AMG-510) is an NDA-approved drug from Amgen, Inc. with Priority status, receiving its PDUFA Goal Date on August 16, 2021. The application number is 214665. The approval date is January 16, 2025.
In efficacy studies, the median overall survival (OS) for Nivolumab was 9.2 months, with an objective response rate (ORR) of 20%. For Pembrolizumab (TPS >= 50%), median OS was 14.9 months compared to 8.2 months for docetaxel, and ORR was 30% versus 8% for docetaxel. Real-world median progression-free survival (PFS) for KRAS G12C-mutated NSCLC (First Line) was 6.1 months (95% CI: 4.4, 9.3), and for KRAS G12C-mutated NSCLC (Second Line) was 3.2 months (95% CI: 2.1, 5.3).
Safety data from 204 patients with KRAS G12C NSCLC showed serious adverse reactions in 50% of patients, with pneumonia at 8% and hepatotoxicity at 3.4%. Permanent discontinuation due to adverse reactions occurred in 9% of patients, with hepatotoxicity accounting for 4.9%. The incidence of ILD/pneumonitis was 1.5%, and hepatotoxicity incidence was 25%.
Key figures — cited to the source page
| Median OS (Pembrolizumab vs docetaxel, TPS >= 50%) | 14.9 vs 8.2 | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.30 |
| ORR (Pembrolizumab vs docetaxel, TPS >= 50%) | 30 vs 8 | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.30 |
| Median (95% CI) real-world PFS (months) for KRAS G12C-mutated NSCLC (First Line) | 6.1 (4.4, 9.3) | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.33 |
| Median (95% CI) real-world PFS (months) for KRAS G12C-mutated NSCLC (Second Line) | 3.2 (2.1, 5.3) | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.33 |
| Serious adverse reactions | 50 | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.20 |
| Permanent discontinuation due to adverse reaction | 9 | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.20 |
| Hepatotoxicity incidence | 25 | Amgen Inc. — Lumakras FDA Review (NDA214665, ORIG 1, 2021), p.20 |
| Approval Date | January 16, 2025 | Amgen Inc. — Lumakras FDA Review (NDA/BLA 214665, 2025), p.1 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.