Regulatory

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.

David Hung

At the time Medivation CEO David Hung was angling for a big premium in the buyout, he insisted that talazoparib was clearly going to be best in class in a field that now includes competing drugs from AstraZeneca, Tesaro and Clovis. 

Talazoparib, he told analysts, was a “multibillion-dollar opportunity.”

That’s what Pfizer paid for, but it’s not likely what it will end up with.

Pfizer’s researchers concluded that there was a 45.8% reduction in the risk of disease progression in the EMBRACA study, which recruited women with HER2-negative breast cancer with germline BRCA mutation. Median PFS was 8.6 months, compared to 5.6 months in the control arm. Compare that to Lynparza’s 42% reduction in the risk of progression, a 7-month versus 4.2-month PFS — or a gap of 2.8 months versus 3 months for talazoparib — and a 59.9% talazoparib vs 28.8% chemo ORR.

Lynparza is one of AstraZeneca’s most successful efforts, now partnered with Merck.


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Molecular Templates Jersey City, NJ
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Molecular Templates Austin, TX
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Molecular Templates Jersey City, NJ
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