Mirati Therapeutics said Tuesday that U.S. regulators accepted an application for its KRAS-blocking lung cancer drug, but the review time will be longer than hoped.
The Food and Drug Administration granted a standard review to the Mirati drug called adagrasib, which sets the approval decision date on Dec. 14 — four months later than the company had requested.
A Mirati spokesperson said the FDA did not offer the company an explanation for why adagrasib won’t be reviewed under a shortened priority review schedule.
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