Bayer: lymphoma drug wins FDA priority review.
(CercleFinance.com) - Bayer said on Wednesday that the US Food and Drug Administration (FDA) has granted a priority review designation for copanlisib in the treatment of relapsed or refractory follicular lymphoma.
The fast-track status on the intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor deals with patients who have received at least two therapies already.
Follicular lymphoma is the most common subtype of indolent non-Hodgkin's lymphoma.
With the priority review, the FDA aims to complete its review within six months, compared to 10 months under standard review.
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