Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC

The US Food and Drug Administration (FDA) is scheduled to review an application submitted by Amgen (NASDAQ: AMGN) for the full registration of its pioneering KRASG12C inhibitor, Lumakras (sotorasib), in October this year. The treatment targets locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). Amgen announced this development this week, noting that Lumakras currently holds an accelerated approval in the US, granted in 2021 for the same indication.

Lumakras’ Potential in Other Solid Tumors
According to Amgen’s press release, Lumakras is under development for the treatment of other solid tumors, including colorectal cancer (CRC). This indicates the company’s commitment to expanding the therapeutic potential of Lumakras beyond lung cancer, highlighting its broad implications in oncology.-Fineline Info & Tech

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