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Pfizer bags an FDA OK for PARP player talazoparib — now the hard part begins

Pfizer has picked up an approval for talazoparib, its PARP inhibitor for a genetically defined line of breast cancer. And now the pharma player can jump into a crowded market where AstraZeneca’s rival Lynparza is way out in front of the pack.

The Pfizer drug, which is hitting the market as Talzenna, figured prominently in Pfizer’s $14 billion Medivation buyout. The then Medivation CEO David Hung pitched talazoparib as a blockbuster-to-be as Sanofi stepped up first with an offer. Now Pfizer gets to find out just how much it can make as the fourth entry in the field, behind Clovis and Tesaro as well.

The approval from the FDA marks the 46th new drug approval from CDER this year, tying the record for all of last year and leaving the agency poised to surge to an all-time record high well before the end of the year. The FDA helpfully provided a snap run-through for Pfizer, putting the drug on a priority review path.

The PARP crowd works along simple lines, disrupting DNA mechanisms for self repair and putting cancer cells on a path to destruction. And this new entry for BRCA-mutated cancer won an OK with a mean progression free survival rate of 8.6 months compared to 5.6 months for a chemo arm.

That’s all well and good, explaining the drug’s presence on CEO Ian Read’s list of late-stage reasons why he was confident in Pfizer’s pipeline. But the OK comes 4 years after AstraZeneca provided the market-leading OK for a PARP in the US. Since then, it’s allied with Merck and continued to expand the drug’s label. 

AstraZeneca has already offered similar risk reduction figures for breast cancer, which will make Pfizer’s job that much tougher.

In a few days AstraZeneca and Merck will be putting the SOLO-1 data on display at ESMO, highlighting its activity in ovarian cancer. And the giant partners have more studies underway as they continue to build the blockbuster in new markets, including China. 

BioMarin, which sold the drug to Medivation, is getting a $15 million milestone payment with the approval today.


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