Watch out Tesaro, AstraZeneca and Merck get FDA OK for broad use of Lynparza

Sean Bohen, AstraZeneca

AstraZeneca and its new Big Pharma partner Merck have picked up the FDA’s approval for the broad use of Lynparza, which will put it directly in the marketing path being blazed by Tesaro.

Like Tesaro’s Zejula, Lynparza (olaparib) can now be used as a maintenance therapy for recurrent ovarian cancer, regardless of BRCA mutation status. And regulators also OK’d an easier dosing regimen, with two tablets twice a day instead of eight capsules daily.

Lynparza was originally restricted to a group of patients who had failed multiple therapies.

The broad approval marks another key advance for AstraZeneca, which sold co-development and co-commercialization rights to Merck a few weeks ago for $1.6 billion upfront. AstraZeneca has been marketing off a variety of assets over the last two years as it looks to engineer blockbuster gains in oncology.

The FDA’s expanded label includes data from the Phase III SOLO-2 study, where progression-free survival was 19.1 months on olaparib vs. 5.5 months on placebo, notes Jefferies Eun Yang.

Yang adds that now that three PARPs are angling for market share — including Clovis drug Rubraca — the much buzzed about possibility of a buyout for Tesaro has diminished considerably.

Tesaro shares $TSRO slid 3.5% Thursday afternoon.

Lynparza was the first PARP to hit the market, and AstraZeneca followed up on the accelerated OK with more studies demonstrating its effectiveness in ovarian cancer. This drug has proven to be a key part of AstraZeneca’s case that it can make a comeback with its oncology portfolio — a case that took a nasty hit with the recent first-round flop for its combo of Imfinzi and the CTLA-4 drug tremelimumab.

Merck paid handsomely to partner on this drug, which it will now take into its own combo studies with its PD-1 star Keytruda while AstraZeneca follows up with Imfinzi. According to a story from Reuters, AstraZeneca and Merck are lining up an application on breast cancer, with studies underway on prostate and pancreatic cancer.

AstraZeneca CMO Sean Bohen said:

Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women. Today’s approvals validate more than 10 years of dedicated research behind Lynparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.

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