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After three deals, FDA approval talazoparib joins PARP party

October 16, 2018 10:50 PM UTC

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of Talzenna's December PDUFA date. FDA concurrently approved BRACAnalysis CDx from Myriad Genetics Inc. (NASDAQ:MYGN) as a companion diagnostic for Talzenna.

Pfizer gained Talzenna in 2016 through its $14 billion acquisition of Medivation Inc., which itself had acquired talazoparib from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN). The compound originated at LEAD Therapeutics Inc., which BioMarin acquired in 2010 for $18 million upfront and up to $79 million in milestones. ...