Amgen Wins World-First Lumakras Approval, Faces Challenge Of COVID-Era Launch
US FDA Cleared KRAS G12C Inhibitor For Second-Line NSCLC
Commercial EVP Murdo Gordon said launching sotorasib during the pandemic is a tougher challenge than encouraging doctors to screen lung cancer patients for KRAS G12C mutations and raising patient awareness.
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Adagrasib may carve out a niche as the superior drug in colorectal cancer, but lung cancer – where Lumakras already is approved – is a larger market where Amgen has a big lead.
Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.
Harvard Medical School’s Dr. Bruce Chabner, Bayer Pharma’s global head of research and Roivant Sciences founder, among others, share their views on the challenges and path ahead for KRAS inhibitors and other oncology modalities including CAR-T therapy.