Krazati(adagrasib)

Krazati (adagrasib) is an NDA-approved drug for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. The recommended dosage regimen is 600 mg orally twice daily. The application received Accelerated Approval with a Standard Review Priority.

In a single-arm, multicenter clinical trial with an efficacy population of 112 patients, Krazati demonstrated an overall response rate (ORR) of 43% (95% CI: 34, 53). The median duration of response (DOR) was 8.5 months (95% CI: 6.2, 13.8), with 58% of responders having a DOR of 6 months or greater. For comparison, median overall survival for immunotherapy was 21-28 months, and for chemotherapy alone was 10-20 months.

Safety data from 188 patients with NSCLC showed that serious adverse reactions occurred in 57% of patients, and fatal adverse reactions occurred in 11%. Permanent discontinuations due to adverse reactions were observed in 13% of patients, while 82% experienced study treatment interruptions or dose reductions. The median duration of exposure in the safety database was 5.6 months.