Mega-blockbuster? Pfizer lines up for a snap review of its PARP drug talazoparib — and a launch into a crowded market
Pfizer $PFE gets to cut in line at the FDA with its application for the PARP inhibitor talazoparib, which is likely headed for a market showdown with a slate of rivals.
Bought out in the $14 billion Medivation acquisition, Pfizer has steered talazoparib through a successful, though distinctly unspectacular, Phase III program for patients with germline BRCA-mutated, HER2-negative breast cancer. And now the agency has offered Pfizer a priority review, putting a decision deadline in December and giving agency commissioner Scott Gottlieb an opportunity to follow through on his promise to add competing drugs to the marketplace in search of lower prices.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.