TESARO (TSRO) Ovarian Cancer Drug Zejula Gets Approval In EU

TESARO, Inc. (NASDAQ:TSRO) announced that the European Commission has granted marketing authorization to its PARP inhibitor, Zejula, as monotherapy for the maintenance treatment of women with recurrent ovarian cancer. The drug is the first approved PARP inhibitor in Europe, which does not require BRCA mutation or other biomarker testing.

The marketing approval in EU has boosted prospects of Zejula, which is already marketed in the United States. The approval in EU was expected as the drug was recommended by the Committee for Medicinal Products for Human Use in September.

A look at TESARO’s share price movement so far this year shows that the company has underperformed the industry. While the stock fell 37.9%, the industry registered a gain of 1.4%.

The approval was based on data from an international phase III study, ENGOT-OV16/NOVA, which showed clinically meaningful increase in progression-free survival. . The study evaluated the drug in recurrent ovarian cancer patients who had achieved either a partial response or complete response to their most recent platinum-based chemotherapy.

TESARO is planning to launch the drug in Germany and UK by the end of this year and in other European countries next year.

PARP inhibitors have bright prospects, given their tremendous demand. However, Zejula will face competition from other approved PARP inhibitors, which include AstraZeneca (NYSE:AZN) / Merck’s (NYSE:MRK) Lynparza and Clovis Oncology, Inc.’s (NASDAQ:CLVS) Rubraca. However, Rubraca is under review in Europe.

TESARO claims that Zejula is the most frequently prescribed PARP inhibitor for treating ovarian cancer since its launch in the United States. The sales numbers show better performance by Zejula,

Zejula has generated sales of more than $65 million in the first six months of its launch in the United States, whereas Lynparza’s U.S. sales were $60 million in that period. Also, Rubraca’s sales were $31.5 million.

Similar adoption of the drug in Europe will aid the company.

Approximately 45,000 women are diagnosed with ovarian cancer each year in Europe and more than 22,000 women are diagnosed annually in Europe. Ovarian cancer is the sixth-most common form of cancer and the fifth-most frequent cause of cancer death.

However, Lynparza’s recent approval in the second-line setting can hurt Zejula’s sales.

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TESARO carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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