Tesaro Announces Opening of Niraparib Expanded Access Program for U.S. Patients With Ovarian Cancer
January 17 2017 - 8:01AM
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced the opening of an expanded access program
(EAP) in the United States for the investigational PARP inhibitor,
niraparib. Through this program, niraparib is being made available
for eligible women with recurrent epithelial ovarian, fallopian
tube, or primary peritoneal cancer following a complete or partial
response to platinum-based chemotherapy. Healthcare professionals
can learn more about the niraparib EAP by visiting
www.niraparibEAP.com. An EAP for niraparib in Europe is planned to
open in the first half of 2017, and will be initiated on a
country-by-country basis.
Expanded access programs enable patients with
serious or life-threatening illnesses who do not otherwise qualify
for participation in a clinical trial, and for whom there are no
comparable or satisfactory alternate therapies, to access
investigational medicines.
“Ovarian cancer is the fifth most frequent cause
of cancer death among women in the United States, yet there have
been few advances in the treatment of ovarian cancer in over a
decade,” said Mary Lynne Hedley, Ph.D., President and COO of
TESARO. “The niraparib EAP will provide a mechanism by which
eligible women with ovarian cancer may benefit from access to this
investigational therapy, which has been accepted for priority
review by the U.S. FDA.”
About the Niraparib Expanded Access
ProgramThe niraparib EAP is a program for women with
recurrent, ovarian, fallopian tube, or primary peritoneal cancer
following a complete or partial response to platinum. This EAP is
being administered on behalf of TESARO by the Idis Managed Access
division of Clinigen Group plc. U.S. based healthcare professionals
seeking more information about the niraparib EAP can call Idis
Managed Access at 1-877-768-4303 or email
niraparibUSEAP@clinigengroup.com for further details. Patients who
are interested in enrolling in the niraparib EAP should speak with
their physician to understand if niraparib is an appropriate
option. Niraparib is an investigational agent and, as such, has not
been approved by the U.S. Food and Drug Administration (FDA) or any
other regulatory agencies in any markets. Additional information
about the niraparib EAP, including a list of Frequently Asked
Questions, is available at www.niraparibEAP.com.
An EAP for niraparib in Europe is planned to
open in the first half of 2017, and will be initiated on a
country-by-country basis.
About NiraparibNiraparib is an
oral, once-daily PARP inhibitor that is currently being evaluated
in three 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 who have received first-line
treatment for ovarian cancer (the PRIMA trial), a registrational
Phase 2 trial in patients who have received multiple lines of
treatment for ovarian cancer (the QUADRA trial), and a Phase 3
trial for the treatment of patients with germline BRCA-mutated,
metastatic breast cancer (the BRAVO trial). Several combination
studies are also underway, including trials of niraparib plus
pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has
licensed rights to develop and commercialize niraparib specifically
for patients with prostate cancer worldwide, except in Japan.
The niraparib New Drug Application (NDA) has
been accepted for priority review by the FDA and is supported by
data from the ENGOT-OV16/NOVA trial, a double-blind,
placebo-controlled, international Phase 3 study that enrolled 553
patients with recurrent ovarian cancer following complete or
partial response to their most recent platinum-based chemotherapy.
The full results of the ENGOT-OV16/NOVA trial were presented in
detail at the European Society for Medical Oncology (ESMO) 2016
Congress in Copenhagen on October 8, 2016 by Dr. Mansoor Raza
Mirza, M.D., Medical Director of the Nordic Society of Gynecologic
Oncology (NSGO) and principal investigator. These data were
simultaneously published in the New England Journal of
Medicine.
Niraparib is an investigational agent and, as
such, has not been approved by the U.S. FDA, European Medicines
Agency (EMA), or any other regulatory agencies.
About Ovarian
CancerApproximately 22,000 women are diagnosed each year
with ovarian cancer in the United States, and more than 65,000
women are diagnosed annually in Europe. Ovarian cancer is the fifth
most frequent cause of cancer death among women. Despite high
response rates to platinum-based chemotherapy in the second-line
advanced treatment setting, approximately 85% of patients will
experience recurrence within two years. If approved, niraparib may
address the difficult “watchful waiting” periods experienced by
patients with recurrent ovarian cancer in between cycles of
platinum-based chemotherapy.
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.
Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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