FDA panel finds results from key Amgen Lumakras study unreliable
Iryna Drozd
An FDA advisory committee dealt a blow to full approval for Amgenâs (NASDAQ:AMGN) lung cancer drug Lumakras, deciding that results from a key clinical study for the therapy were unreliable. 
In a vote of 10 to 2, the committee voted that the studyâs primary endpoint, progression-free survival, could not be reliably interpreted in a Phase 3 study for Lumakras called CodeBreaK 200.
Shares of Amgen were down fractionally following the vote. 
Amgen had submitted the study to support full approval of Lumakras for the treatment of non-small cell lung cancer, or NSCLC, with KRAS G12C mutations. The drug received accelerated approval for that indication in 2021, but needed more data for full approval.
While the FDA is not bound to the recommendations and opinions of its advisory committees, it generally follows them. The agency is expected to decide on whether to grant full approval to Lamakras by late December.
Earlier this week, FDA briefing documents released ahead of the meeting indicated reviewers were concerned CodeBreak 200 had systemic biases. In one particular document, FDA reviewers commented that features of CodeBreaK 200 âdid not appear consistent with an adequate and well-controlled trial.â
Meanwhile, shares of Mirati Therapeutics (NASDAQ:MRTX), which has developed a rival KRAS inhibitor drug called Krazati, soared 26% following the vote.
Mirati is expected to report Phase 3 data on Krazati later this month. The product received accelerated approval for the treatment of NSCLC with KRAS G12C mutations in December. 
Shares of Mirati were also stoked Thursday by a report that Sanofi (SNY) was interested in acquiring the company.


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