FDA shoves Bayer’s lymphoma drug copanlisib into the spotlight with its promise of a speedy review
Bayer is getting VIP treatment at the FDA for its mid-stage lymphoma drug copanlisib. Regulators agreed to give the drug a priority review — lopping 4 months off the standard 10 month cycle — and heightening its chances for a quick OK.
The PI3K drug — an IV therapy targeting PI3K-αlpha and delta — first gained some attention in late March when investigators reported that the treatment scored positive data for indolent non-Hodgkin lymphoma.
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