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Corporate News Blog - EMA Grants Positive CHMP Opinion to Tesaro’s Ovarian Cancer Drug

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LONDON, UK / ACCESSWIRE / September 18, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Tesaro, Inc. (NASDAQ: TSRO), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=TSRO. The Company announced on September 15, 2017, that the European Medicines Agency`s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a positive view for marketing authorization application for ZEJULA® (niraparib), as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy. For immediate access to our complimentary reports, including today's coverage, register for free now at:


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The recommendation will be referred to the European Commission (EC), for receiving marketing authorization of ZEJULA in the European Union. Once approved by the EC, ZEJULA would be the first oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.

ZEJULA's NOVA Trial, Phase-3 Study

  • The marketing authorization application is supported by data from the ENGOT-OV16/NOVA trial, an international Phase-3 study of ZEJULA.
  • The study enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. Two-thirds of study participants did not have germline BRCA mutations.
  • Results indicated that ZEJULA significantly increased progression-free survival (PFS) in patients with and without germline BRCA mutations compared to the control arm.
  • It was also found that treatment with ZEJULA reduced the risk of the disease progression or death by 73% in patients with germline BRCA mutations and by 55% in patients without germline BRCA mutations, with similar magnitude of benefit for patients entering the trial with a PR or a CR.
  • The most common adverse reactions to ZEJULA included thrombocytopenia, anemia, neutropenia, and hypertension. The majority of hematologic adverse events were successfully managed via dose modification.

Phase-3 NOVA Trial Generated Unsurpassed Efficacy Results in Patients with Recurrent Ovarian Cancer

Mary Lynne Hedley, Ph.D., President and COO of TESARO, stated that ZEJULA was studied with the highest level of clinical rigor, and the Phase-3 NOVA trial generated unsurpassed efficacy results in patients with recurrent ovarian cancer, including women without germline BRCA mutations who have the most challenging prognosis and few treatment options. She added that the positive CHMP opinion brings TESARO one step closer to providing important new medicine to patients with recurrent ovarian cancer in Europe.

TESARO to Launch ZEJULA across Multiple Countries in Europe

Orlando Oliveira, Senior Vice President and General Manager of TESARO International, stated that the Company is rapidly globalizing its mission of providing transformative oncology therapies to those who need them most. Upon final approval by the EC, the Company intends to launch ZEJULA across multiple countries in Europe where it already has an established, direct presence, beginning in the fourth quarter.

ZEJULA Received FDA Approval in March 2017

News release suggests that on March 27, 2017, TESARO received approval from FDA for ZEJULA, becoming the first PARP inhibitor to be approved by the FDA that did not require BRCA mutation or another biomarker testing. On April 19, 2017, TESARO announced the availability of ZEJULA by prescription in the United States.


ZEJULA (niraparib) is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Ovarian Cancer in Europe

Europe has one of the highest incidences of ovarian cancer in the world with around 45,000 women diagnosed there every year. Ovarian cancer affects approximately 1.3 in 10,000 people in the European Union. Despite high initial response rates to platinum-based chemotherapy, approximately 85% of women with advanced ovarian cancer will experience a recurrence of the disease after first-line treatment.

About Tesaro Inc.

Founded in 2010, TESARO is a biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. The Company is headquartered in Waltham, Massachusetts.

Last Close Stock Review

On Friday, September 15, 2017, the stock closed the trading session at $117.16, advancing 1.67% from its previous closing price of $115.24. A total volume of 1.25 million shares have exchanged hands, which was higher than the 3-month average volume of 1.17 million shares. Tesaro's stock price rallied 3.69% in the last one month and 18.60% in the previous twelve months. The stock currently has a market cap of $6.24 billion.

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