ADELAIDE, Australia, June 23, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced nine presentations of rolapitant data at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer, June 23 to 25, 2016, in Adelaide, Australia.
“Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. At this year’s MASCC/ISOO Annual Meeting, which is the premier global event for supportive care in cancer, we are pleased that data will be presented that demonstrate the activity of rolapitant in patients at high risk for CINV, including those who are receiving cisplatin- and carboplatin-based chemotherapy for gynecologic and lung cancers,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “With our Marketing Authorisation Application (MAA) for oral rolapitant under review by the European Medicines Agency (EMA) and our New Drug Application (NDA) for intravenous rolapitant under review by the U.S. FDA, we look forward to globalizing our mission of improving the lives of people bravely facing cancer.”
Please visit TESARO at Booth #3 for information about VARUBI (rolapitant) and our pipeline.
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer
Abstract: MASCC-0318, Poster Presentation, Thursday, June 23, 2016
Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy
Abstract: MASCC-0322, Poster Presentation, Thursday, June 23, 2016
Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients aged <65 versus ≥65 years
Abstract: MASCC-0432, Poster Presentation, Thursday, June 23, 2016
Single ascending dose pharmacokinetics of rolapitant administered intravenously at supratherapeutic doses in healthy volunteers
Abstract: MASCC-0489, Poster Presentation, Thursday, June 23, 2016
Effects of rolapitant administered intravenously on the pharmacokinetics of cooperstown cocktail (midazolam [CYP3A4], omeprazole [CYP2C19], warfarin [CYP2C9], caffeine [CYP1A2], and dextromethorphan [CYP2D6]) in healthy volunteers
Abstract: MASCC-0492, Poster Presentation, Thursday, June 23, 2016
Effects of rolapitant administered intravenously on the pharmacokinetics of digoxin (P-gp) and sulfasalazine (BCRP) in healthy volunteers
Abstract: MASCC-0494, Poster Presentation, Thursday, June 23, 2016
A single-dose bioequivalence study of rolapitant following oral and intravenous administration in healthy volunteers
Abstract: MASCC-0485, Oral Poster Presentation, Friday, June 24, 2016 from 2:00 PM to 3:30 PM
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer
Abstract: MASCC-0321, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM
Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer
Abstract: MASCC-0316, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM
About VARUBI® (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated 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. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full the U.S. prescribing information, including additional important safety information, available at www.varubirx.com.
An intravenous formulation of rolapitant is currently under review by the FDA, with a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. An MAA for oral rolapitant is currently under review by the EMA. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in expectations with respect to regulatory submissions and approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016.
Investor/Media Contact: Jennifer Davis Sr. Director, Corporate Development & Investor Relations +1.781.325.1116 or firstname.lastname@example.org