Tesaro Gets Approval For Zejula, Expect U.S. Launch Late April

TESARO Inc (NASDAQ: TSRO) announced the FDA approval of Zejula (niraparib) in recurrent ovarian cancer maintenance with a broad label. The approval came in three months ahead of schedule and the launch is expected in late April, Baird’s Michael E. Ulz said in a report.

While reiterating a Neutral rating and a price target of $165 for Tesarao, Ulz mentioned that the market was highly competitive. Two competing PARP (poly ADP ribose polymerase) inhibitors had already been approved, AstraZeneca plc (NYSE: AZN)'s Lynparza and Clovis Oncology Inc (NASDAQ: CLVS)'s Rubraca, while there were several other players with PARPs in late-stage development, including Pfizer Inc. (NYSE: PFE)'s talazoparib and AbbVie Inc (NYSE: ABBV)'s veliparib.

Zejula Approval

Zejula was approved by the FDA for “the maintenance of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have responded (partial or complete) to platinum-based chemotherapy,” the analyst wrote.

The label is broad and the U.S. launch is expected in late April, at which time Tesaro would provide insight into pricing. Niraparib is under regulatory review in Europe, and Ulz expects a launch by end of 2017. He estimated peak worldwide sales of $1.5 billion in ovarian cancer.

“Overall, while we are encouraged by these updates, we maintain our Neutral rating given pending competitive PARP data (mid-2017),” Ulz commented.

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