Shots:

• The approval was based on the P-II study (KRYSTAL-1) evaluating Krazati (600mg, BID) in 116 patients with KRASG12C-mutated advanced NSCLC which showed a positive benefit-risk profile, ORR (43%) with 80% of patients achieved disease control & m-DoR was 8.5mos.
• In a pooled efficacy analysis incl. P-I/Ib NSCLC & P-II NSCLC cohorts from the (KRYSTAL-1) study, the results showed an ORR (44%), DCR (81%) based on BICR, m-DoR of 12.5mos. and m-OS of 14.1mos., AEs leading to permanent discontinuation (13%)
• The company launches Mirati & Me, a comprehensive program to provide access to patients, caregivers & oncology community to use the treatment & also offers financial, educational & emotional support services to eligible patients

Ref: PRNewswire | Image: Mirati Therapeutics