Amgen’s Lumykras (sotorasib) Receives EC’s Approval for the Treatment of Non-Small Cell Lung Cancer
Shots:
- The EC has granted conditional marketing authorization for Lumykras (KRASG12C inhibitor) in adults with advanced NSCLC with KRAS G12C mutation who have progressed after one prior line of systemic therapy
- The approval is based on the P-II (CodeBreaK 100) trial to evaluate Lumykra (960mg, PO, qd) in 126 patients with advanced NSCLC which showed an ORR (37.1%), m-DoR of 11.1mos. along with a favorable benefit-risk profile of Lumykras
- Lumykra is the 1st targeted therapy to be approved in the EU & is also being evaluated in multiple P-Ib (CodeBreaK 101) studies as monothx. and in combination therapy for the treatment of multiple advanced solid tumors
Ref: PR Newswire | Image: Fierce Pharma
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