Amgen's Lumakras (sotorasib) Receives the US FDA's Approval as the First KRAS Blocking Cancer Therapy
Shots:
- The approval is based on the CodeBreaK 100 trial evaluating the efficacy & tolerability of Lumakras (960mg- qd) in 124 patients with KRAS G12C mutation-positive NSCLC whose disease had progressed after prior treatment with immunotherapy or CT
- Results: ORR (36%); DCR (81%); mDoR (10 mos.); durable response with a positive benefit-risk profile- 9% showed permanent discontinuation due to AEs
- The company is conducting biomarker testing & a patient support program for NSCLC. The therapy is also being studied in multiple other solid tumors
Ref: PRNewswire | Image: BioSpace
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