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TESARO, Inc.

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TESARO PROVIDES PIPELINE UPDATE AT ASCO INVESTOR BRIEFING

Rolapitant IV NDA accepted for review by FDA; PDUFA date is January 11, 2017
Sufficient PFS events reached for data analysis of both cohorts of Phase 3 niraparib NOVA trial; data expected in Q2 2016
IND for TSR-022 (anti-TIM-3 antibody) cleared by FDA; Phase 1 study to begin in mid-2016

CHICAGO, June 04, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today provided an update on its clinical development pipeline during an investor briefing and webcast held in conjunction with the American Society for Clinical Oncology (ASCO) 2016 annual meeting.

During the investor briefing, TESARO announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. The NDA for rolapitant IV is supported by data from a clinical program of approximately 350 subjects, and included a bioequivalence study and several other supportive non-clinical and clinical studies.

TESARO also provided an update on its Phase 3 NOVA trial of niraparib in patients with ovarian cancer. A sufficient number of progression free survival (PFS) events has been reached to trigger data analysis for both cohorts. Data cleaning is underway in preparation for database lock and release of top-line results. Finally, TESARO announced FDA clearance of its Investigational New Drug (IND) application for TSR-022, its anti-TIM-3 antibody candidate. A Phase 1 study for TSR-022 is planned to begin in mid-2016.

"We continue to make significant progress with our pipeline of oncology product candidates. The acceptance of the rolapitant IV NDA and clearance of TSR-022 IND are important milestones for TESARO and demonstrate our commitment to advancing new therapeutic options for patients," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Our NOVA study results will be the first data from a prospectively designed, randomized, Phase 3 trial of a PARP inhibitor, and we look forward to sharing these data later this quarter."
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Source: press release, 6/04/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=974299

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TESARO SUBMITS NEW DRUG APPLICATION FOR INTRAVENOUS ROLAPITANT TO THE U.S. FOOD AND DRUG ADMINISTRATION

WALTHAM, Mass., March 14, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant to the U.S. Food and Drug Administration (FDA).

Rolapitant is a substance P/neurokinin-1 (NK-1) receptor antagonist that is marketed in tablet formulation by TESARO in the United States under the brand name VARUBIĀ®. The FDA approved VARUBI on September 1, 2015, for use in combination with other antiemetic agents in adults, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

"TESARO is committed to advancing new therapeutic options for patients with cancer, and the NDA submission for IV rolapitant represents a significant milestone for the Company," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "By developing an intravenous formulation of rolapitant, our goal is to provide oncologists additional flexibility in their choice of antiemetic regimens."

The NDA for IV rolapitant is supported by data from a clinical program that enrolled more than 400 subjects and included a bioequivalence study and several other supportive non-clinical and clinical studies. TESARO anticipates a standard 12-month review timeline for the IV rolapitant NDA.
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Source: press release, 3/14/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=960409

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Leon (Lonnie) O. Moulder, Jr., Chief Executive Officer, gave guidance for the filing of the NDA for IV Rolapitant. He stated, "The NDA submission for the IV formulation of Rolapitant is on track to occur within the next few weeks and we are already planning for commercial launch of Varubi IV in the early 2017 timeframe."
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
Rolapitant IVOncologyChemotherapy-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 FDA: PDUFA DATE

Dates: 2017-01-11

Results: Pending