Amgen’s Lumykras (sotorasib) Receives CHMP’s Positive Opinion for the Treatment of KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

November 15, 2021 Auto Bot Amgen, CHMP, Non-Small Cell Lung Cancer, regulatory, Sotorasib 0

Shots:

  • The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorization for Lumykras to treat advanced NSCLC with KRAS G12C mutation & who have progressed after 1 prior line of systemic therapy
  • The CHMP opinion is based on the P-II CodeBreaK 100 trial to evaluate sotorasib (960mg, qd, PO) in 126 patients with KRAS G12C mutation-positive NSCLC. The result showed ORR (37.1%); m-DoR (11.1mos.); DCR (80.6%); m-OS (12.5mos.) & has a favorable efficacy & tolerability profile
  • If approved, Lumykras will be 1st targeted therapy for KRAS G12C mutation. The EC will now review the CHMP recommendation to approve medicines for EU with an expected EC’s decision in mid-Jan’22

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

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