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TESARO ANNOUNCES ACCEPTANCE FOR REVIEW OF NIRAPARIB MARKETING AUTHORIZATION APPLICATION BY EMA

WALTHAM, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the Marketing Authorisation Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy. With this acceptance, the review of the niraparib marketing authorisation application in the Centralised Procedure will now begin.

"TESARO is committed to improving the lives of patients with cancer by responsible development and commercialization, and the validation of the niraparib MAA represents a significant milestone for the Company," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We believe niraparib could become an important new treatment option for patients. We look forward to working with the EMA during the review process and expect to complete our rolling NDA submission to the FDA for niraparib imminently."

The niraparib MAA is supported by data from the ENGOT-OV16/NOVA trial, which is a double-blind, placebo-controlled, international Phase 3 study of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. The full results of the NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016 and were published at the same time in The New England Journal of Medicine.

"The validation of our MAA for niraparib today marks an important step towards globalizing our mission of providing transformative therapies to people bravely facing cancer," said Orlando Oliveira, Senior Vice President and General Manager of TESARO International. "With the MAA for oral rolapitant already under review by the EMA, we are well positioned for two potential product launches in Europe in 2017."
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Source: press release, 10/27/16.

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TESARO ANNOUNCES VALIDATION OF MARKETING AUTHORISATION APPLICATION FOR ORAL ROLAPITANT BY THE EUROPEAN MEDICINES AGENCY

WALTHAM, Mass., March 23, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the Marketing Authorisation Application (MAA) for oral rolapitant has been submitted to and validated by the European Medicines Agency. Rolapitant is a substance P/neurokinin-1 (NK-1) receptor antagonist that is marketed by TESARO in the United States under the brand name VARUBIĀ®.

"TESARO is committed to advancing new therapeutic options for patients with cancer, and the oral rolapitant MAA submission represents a significant milestone for the Company," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We believe rolapitant could become an important new treatment option for the prevention of nausea and vomiting for patients in Europe who are undergoing emetogenic chemotherapy."

The oral rolapitant MAA is supported by data from four controlled studies covering a spectrum of patients receiving emetogenic chemotherapy. One study enrolled patients receiving moderately emetogenic chemotherapy (MEC), and three studies enrolled patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). The top-line results of each of the three Phase 3 studies of rolapitant were presented in detail at the American Society for Clinical Oncology (ASCO) annual meeting in June 2014. Oral rolapitant was approved by the U.S. Food and Drug Administration on September 1, 2015 and is marketed by TESARO in the United States under the brand name VARUBIĀ®.

"TESARO has an exciting pipeline of oncology therapeutics, and with the filing of our MAA for oral rolapitant today and our planned niraparib MAA filing in the second half of this year, we look forward to globalizing our mission of providing transformative therapies to people bravely facing cancer," said Orlando Oliveira, Senior Vice President and General Manager of TESARO International.
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Source: press release, 3/23/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=961921

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Leon (Lonnie) O. Moulder, Jr., Chief Executive Officer, gave guidance for the submission of the MAA for oral Rolapitant. He stated, "We also plan to submit the oral Rolapitant MAA to the EMA in Q2, 2016."
Source: Q4 2015 earnings conference call, 2/25/16.

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Mary Lynne Hedley, Ph.D., President, COO, gave guidance for the regulatory situation regarding Rolapitant. She stated, "We have received clear feedback from FDA regarding our submission and we are on-track to complete and submit the NDA within the next few weeks which is in line with our Q1 target. As a reminder, we are anticipating a 12 months review for this application. We are also busy preparing the MAA submission for oral rolapitant which we expect to submit to EMA during the next several weeks.
Source: Q4 2015 earnings conference call, 2/25/16.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
RolapitantOncologyChemotherapy-Induced Nausea and Vomiting (CINV)NK-1 receptor antagonistNK-1 receptor

Mechanism of action: Rolapitant is a potent, highly selective, long-acting NK-1 receptor antagonist being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). Neurokinin-1 (NK-1) receptors are highly concentrated in the vomiting center of the brain, and bind a neurokinin called Substance P. Activation of NK-1 receptors by Substance P plays a central role in eliciting CINV. By blocking the interaction of Substance P at the NK-1 receptor, NK-1 receptor antagonists have demonstrated improvement in the management of nausea and vomiting experienced by patients receiving chemotherapy.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-04-21

Results: Pending