TESARO Ovarian Cancer Drug Zejula Gets Positive CHMP Opinion

TESARO, Inc. (NASDAQ:TSRO) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval of its ovarian cancer drug, Zejula (niraparib).

TESARO is seeking approval of the oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor as monotherapy for the maintenance treatment of women suffering from recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy.

We note that the CHMP’s positive opinion on Zejula will be reviewed by the European Commission.

We remind investors that the drug received approval in the United States in March 2017 for the same indication and was launched in April. It recorded a sales of $25.9 million in the second quarter.

Shares of the company were up 1.7% on Friday. However, a look at TESARO’s share price movement so far this year shows that the company has underperformed the industry. While the stock fell 12.9%, the industry registered a gain of 2.8%.

The marketing application was submitted based on results from the international phase III study, ENGOT-OV16/NOVA in recurrent ovarian cancer patients who had achieved either a partial response or complete response to their most recent platinum-based chemotherapy.

The drug showed a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed phase III trial.

Zejula will be the first PARP inhibitor in Europe that does not require BRCA mutation or other biomarker testing, if approved.

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.

We note that AstraZeneca’s (NYSE:AZN) Lynparza is another PARP inhibitor approved for the treatment of women with advanced ovarian cancer who have received previous treatment with three or more prior chemotherapy medicines or a combination of chemotherapy medicines and have a certain type of abnormal inherited BRCA gene. Clovis Oncology’s (NASDAQ:CLVS) Rubraca is also approved for the same indication.

TESARO, Inc. Price and Consensus

TESARO, Inc. Price and Consensus | TESARO, Inc. Quote

Zacks Rank & Stocks to Consider

TESARO currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is Heska Corporation (NASDAQ:HSKA) . The stock carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Heska’s earnings estimates increased 4.7% to $2.00 for 2017 and 4.9% to $2.13 for 2018 over the last 60 days. The company delivered a positive earnings surprise in each of the four trailing quarters with an average beat of 67.62%. Shares of the company are up 30.75% so far this year.

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