Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

September 14, 2021 Auto Bot Amgen, approval, Health Canada, Lumakras, Non-Small Cell Lung Cancer, regulatory, Sotorasib 0

Shots:

  • The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease had progressed after prior treatment with immunotherapy or CT
  • The 1EPs were centrally assessed ORR. Additionally, the therapy demonstrated a positive benefit-risk profile with rapid, deep, and durable anticancer activity
  • The therapy is also being studied in multiple other solid tumors. The company has completed enrollment in the P-III CodeBreaK 200 study for sotorasib vs docetaxel in patients with the same indication & results of the P-II trial in CRC is expected in later 2021

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

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