Shots:

• The approval was based on the P-II (CodeBreaK 100) clinical trial to evaluate Lumykra (960mg, PO, qd) in 126 patients with advanced NSCLC with KRAS G12C mutation who have progressed after systemic anticancer therapy
• In a P-II trial, patients treated with Lumykra showed an ORR of 37% in 123 evaluable patients & demonstrated durable responses along with a favorable benefit-risk profile. The results were published in The NEJM
• Lumakras is a KRASG12C inhibitor & showed a benefit-risk profile with rapid, deep & durable anticancer activity. The therapy is approved in the UAE, EU, Switzerland, Canada & Great Britain under the FDA's Project Orbis & is also being evaluated in multiple solid tumors

Ref: PR Newswire | Image: Amgen