Shots:

• The EMA's CHMP has adopted a positive opinion recommending the conditional marketing authorization for Lumykras to treat advanced NSCLC with KRAS G12C mutation & who have progressed after 1 prior line of systemic therapy
• The CHMP opinion is based on the P-II CodeBreaK 100 trial to evaluate sotorasib (960mg, qd, PO) in 126 patients with KRAS G12C mutation-positive NSCLC. The result showed ORR (37.1%); m-DoR (11.1mos.); DCR (80.6%); m-OS (12.5mos.) & has a favorable efficacy & tolerability profile
• If approved, Lumykras will be 1st targeted therapy for KRAS G12C mutation. The EC will now review the CHMP recommendation to approve medicines for EU with an expected EC's decision in mid-Jan'22

 Ref: PR Newswire | Image: Amgen