TESARO Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
September 12 2016 - 8:01AM
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to niraparib for the
treatment of patients with recurrent platinum-sensitive ovarian,
fallopian tube, or primary peritoneal cancer. TESARO has initiated
a rolling submission of a New Drug Application (NDA) for niraparib
to the FDA, and intends to complete this submission during the
fourth quarter. The Marketing Authorization Application (MAA) for
niraparib is planned for submission to the European Medicines
Agency (EMA) in the fourth quarter.
The FDA Fast Track designation is designed to
facilitate the development and expedite the review of medicines
that are intended to treat serious conditions and address unmet
medical needs. As part of the Fast Track program, the FDA allows
for the submission of completed portions of an NDA on an
ongoing or rolling basis.
“The initiation of this rolling NDA submission
is a significant milestone for TESARO, and we are committed to
working collaboratively with the FDA to advance the review of the
niraparib application,” said Mary Lynne Hedley, Ph.D., President
and COO of TESARO. “We look forward to presentation of data from
the Phase 3 NOVA trial of niraparib in a Presidential Symposium
session at the European Society for Medical Oncology (ESMO)
congress on October 8.”
NOVA is a double-blind, placebo-controlled,
international Phase 3 trial of niraparib that enrolled more than
500 patients with recurrent ovarian cancer who were in a response
to their most recent platinum-based chemotherapy.
About NiraparibNiraparib is an
oral, once-daily PARP inhibitor that is currently being evaluated
in four ongoing pivotal trials. TESARO is building a robust
niraparib franchise by assessing activity across multiple tumor
types and by evaluating several potential combinations of niraparib
with other therapeutics. The ongoing development program for
niraparib includes a Phase 3 trial in patients with
platinum-sensitive, recurrent ovarian cancer (the NOVA trial); a
Phase 3 trial in patients with first-line ovarian cancer (the PRIMA
trial); a registrational Phase 2 treatment trial in patients with
ovarian cancer (the QUADRA trial); and a Phase 3 trial for the
treatment of patients with BRCA-positive breast cancer (the BRAVO
trial). Several combination studies are also underway, including
trials of niraparib plus pembrolizumab and bevacizumab.
Niraparib is an investigational agent and, as
such, has not been approved by the U.S. FDA or any other regulatory
agencies.
About TESAROTESARO is an
oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people bravely facing cancer. For more
information, visit www.tesarobio.com, and follow us on Twitter and
LinkedIn.
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.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our expectation
to complete the rolling NDA submission and submit the MAA for
niraparib in the fourth quarter of 2016 and to present the full
NOVA data set at the European Society for Medical Oncology (ESMO)
meeting on October 8, 2016. Forward-looking statements in this
release involve substantial risks and uncertainties that could
cause our research and pre-clinical development programs, 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, risks related to our intellectual property, the
uncertainties inherent in the execution and completion of clinical
trials, uncertainties surrounding the timing of availability of
data from our clinical trials, risks regarding ongoing discussions
with and actions by regulatory authorities, patient accrual rates
for clinical trials, risks from competitors, and other matters that
could affect the timing of availability of data from or initiation
of our clinical trials, uncertainties regarding regulatory
approvals, uncertainties regarding certain expenditures, risks
related to manufacturing and supply, 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
June 30, 2016.
Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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