ARTICLE | Product Development
Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer
February 14, 2020 1:52 AM UTC
A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel to treat adults with third-line relapsed or refractory large B cell lymphoma. BMS gained the anti-CD19 CAR T cell therapy through its $74 billion acquisition of Celgene Corp. The PDUFA date is Aug. 17.
An NDA for tucatinib from Seattle Genetics Inc. (NASDAQ:SGEN) for tucatinib is under review to treat fourth-line HER2-positive breast cancer in combination with Herceptin trastuzumab and capecitabine. A decision on the small molecule tyrosine kinase inhibitor is due Aug. 20...