ARTICLE | Clinical News
FDA Priority Review for Verastem's duvelisib
April 13, 2018 1:50 PM UTC
Verastem Inc. (NASDAQ:VSTM) said FDA accepted and granted Priority Review to an NDA seeking full approval of duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The NDA is also seeking accelerated approval to treat relapsed or refractory follicular lymphoma (FL). Its PDUFA date is Oct. 5, 2018.
Verastem licensed exclusive, worldwide rights to duvelisib from Infinity Pharmaceuticals Inc. (NASDAQ:INFI) in 2016. ...
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