Mirati gets a standard review for its 'breakthrough' KRAS drug. And that is causing some hand wringing
After the market close on Monday, Mirati issued a statement that the FDA had accepted its application for their KRAS drug adagrasib and is giving it a standard 10-month review, setting a PDUFA date way out toward the end of the year.
That’s not exactly what Mirati investors were looking for. Playing catch-up in lung cancer with Amgen — which got an accelerated approval for sotorasib (Lumakras) following a ferocious 3-year clinical campaign and is now pursuing a confirmatory study of the drug — Mirati was clearly hoping to get the short, snap review and look to get out in the market in the middle of the year. And a STAT piece initially indicated that the early Lumakras approval had triggered the lengthier review at Mirati — something that was then clarified with a remark that the company was not told why they got the standard look-see.
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