Amgen (NASDAQ:AMGN) has received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) seeking full approval for Lumakras (sotorasib) in adult patients with previously-treated KRAS-mutated non-small cell lung cancer (NSCLC). The FDA has mandated an additional confirmatory study to support the drug’s full approval, with completion required by February 2028.
The accelerated approval status granted to Lumakras in 2021 remains in effect, maintaining once-daily dosing at 960 mg. The FDA’s decision aligns with concerns raised by an advisory committee in October, where members expressed skepticism about relying on the primary endpoint of progression-free survival (PFS) in Amgen’s confirmatory study (CodeBreak 200) to assess Lumakras’ benefits.
Amgen has not yet disclosed its plans or next steps for Lumakras following this development. Year-to-date, Amgen’s shares have risen by 8.1%, contrasting with the industry’s 16.1% decline.
Lumakras, following accelerated approval, became the first targeted treatment for KRAS G12C-mutated NSCLC, the most common KRAS mutation in NSCLC patients. Approximately 13% of non-squamous NSCLC patients harbor the KRAS G12C mutation.
Amgen is also evaluating Lumakras in clinical studies as a potential treatment for KRAS G12C-mutated colorectal cancer (CRC). In October, Amgen reported positive data from a phase III study, demonstrating statistically significant superiority in PFS when Lumakras was combined with Vectibix compared to the investigator’s choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic CRC.
This development is expected to benefit rival Mirati Therapeutics (MRTX), which received FDA approval in December 2022 for Krazati, a drug similar to Lumakras, targeting the same patient population. Mirati has recorded encouraging sales from Krazati, and the company is evaluating the drug in the CRC indication as well. Bristol Myers (NYSE:BMY) has also expressed interest in the KRAS G12C space, making a buyout offer for Mirati Therapeutics recently. Bristol Myers is undergoing a transition, shifting its mature product portfolio in the face of new drug competition.
The landscape of KRAS G12C-targeted treatments is dynamic, with multiple companies vying for a share of this market, and developments in this space are closely watched by investors and industry observers.
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