An independent panel of experts advising the U.S. FDA recommended that Clovis Oncology Inc's lung cancer drug
not be approved based on existing trial data.
The panel voted 12-1 against giving the drug an accelerated approval,
and recommended the FDA wait for the results from an ongoing late-stage
trial that compares the drug's effect to that of chemotherapy.
An accelerated approval would allow Clovis to conditionally market
the drug, Rociletinib, based on early evidence of its clinical benefit.
Rociletinib is designed to treat a subset of patients with advanced
non-small cell lung cancer (NSCLC) whose condition has worsened despite
treatment. It targets patients with a genetic mutation known as T790M
that helps tumors evade current lung cancer pills.
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