Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy

May 31, 2021 Auto Bot Amgen, approval, FDA, Lumakras, NSCLC, regulatory, Sotorasib 0

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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

The post Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy first appeared on PharmaShots.