TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, announced today that ZEJULA® (niraparib), an oral,
once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, is now
available by prescription in Germany. ZEJULA is also currently
available for patients in the United Kingdom (UK) who have private
insurance. On November 16, the European Commission (EC) approved
ZEJULA as a monotherapy for the maintenance treatment of adult
patients with platinum-sensitive relapsed high-grade serous
epithelial ovarian, fallopian tube, or primary peritoneal cancer
who are in complete response (CR) or partial response (PR) to
platinum-based chemotherapy. ZEJULA is the first once-daily, oral
PARP inhibitor to be approved in Europe that does not require BRCA
mutation or biomarker testing.
“As we continue to globalize our mission, we
remain committed to enabling access to this important therapy for
patients who have completed platinum-based chemotherapy and have
limited treatment options. In the U.S., where ZEJULA has been
approved since March, it is the most frequently prescribed PARP
inhibitor for patients with ovarian cancer,” said Orlando Oliveira,
Senior Vice President and General Manager of TESARO International.
“The introductions of ZEJULA in Germany and the UK are significant
milestones for TESARO as we bring transformative therapies to
patients with cancer around the globe. With two approved products
in Europe, we are working quickly to make our medicines available
in the 17 European countries where we have a direct presence.”
The EC approval of ZEJULA was based on data from
the clinically rigorous ENGOT-OV16/NOVA trial, a double-blind,
placebo-controlled, international Phase 3 study of ZEJULA that
enrolled 553 patients with recurrent ovarian cancer who had
achieved either a PR or CR to their most recent platinum-based
chemotherapy. The primary endpoint of the trial was progression
free survival (PFS). Approximately two-thirds of study participants
did not have germline BRCA mutations. Progression in the NOVA study
was determined by a robust, unbiased, blinded central review to be
the earlier of radiographic or clinical progression. ZEJULA
significantly increased PFS in patients with or without germline
BRCA mutations as compared to the control arm. Treatment with
ZEJULA reduced the risk of disease progression or death by 73% in
patients with germline BRCA mutations (hazard ratio (HR) 0.27) and
by 55% in patients without germline BRCA mutations (HR 0.45). The
magnitude of benefit was similar for patients entering the trial
with a PR or a CR.
In the ENGOT-OV16/NOVA trial, the most common
grade 3/4 adverse reactions to ZEJULA included thrombocytopenia
(34%), anemia (25%), neutropenia (20%), and hypertension (8%).
Following dose adjustment based on individual tolerability, the
incidence of grade 3/4 thrombocytopenia was low, approximately 1%
after month three. The majority of hematologic adverse events were
successfully managed via dose modification, and discontinuation of
therapy due to thrombocytopenia, neutropenia and anemia occurred in
3%, 2% and 1% of patients, respectively.
The approved starting dose of ZEJULA is 300
milligrams once per day. According to the European summary of
product characteristics (SmPC), in patients below 58 kilograms, a
starting dose of 200 milligrams once per day may be
considered. The most commonly administered dose of ZEJULA over the
course of the Phase 3 NOVA clinical trial was 200 milligrams once
per day, following dose modification. Further exploratory analyses
of the NOVA study indicated that individual dose modification
maintained efficacy and reduced the rate of new adverse
events1.
About Ovarian Cancer in
EuropeEurope has one of the highest incidences of ovarian
cancer in the world with approximately 45,000 women diagnosed each
year2,3. In the European Union, ovarian cancer is the
sixth-most common cancer and the fifth-most frequent cause of
cancer death among women there2,4. Despite high initial response
rates to platinum-based chemotherapy, approximately 85% of women
with advanced ovarian cancer will experience a recurrence of the
disease after first-line treatment5. The efficacy of chemotherapy
also diminishes over time.
About ZEJULA (niraparib)ZEJULA
is a once-daily, oral poly (ADP-ribose) polymerase (PARP) 1/2
inhibitor that is indicated in the European Union as a monotherapy
for the maintenance treatment of adult patients with
platinum-sensitive relapsed high grade serous epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy. In preclinical
studies, ZEJULA concentrates in the tumor relative to plasma,
delivering greater than 90% durable inhibition of PARP 1/2 and a
persistent antitumor effect.
Select Important Safety
InformationMyelodysplastic Syndrome/Acute Myeloid Leukemia
(MDS/AML) was reported in 1.4% of patients receiving ZEJULA vs.
1.1% of patients receiving placebo in the Phase 3 NOVA trial, and
0.9% of patients treated with ZEJULA in all clinical studies.
Discontinue ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia,
anemia and neutropenia) have been reported in patients treated with
ZEJULA. Monitor complete blood counts (CBCs) weekly for the first
month of treatment and modify the dose as needed. After the first
month, it is recommended to monitor CBCs for the next 10 months of
treatment, and periodically after this time. Based on individual
laboratory values, weekly monitoring for the second month may be
warranted.
Hypertension and hypertensive crisis have been
reported in patients treated with ZEJULA. Pre-existing hypertension
should be adequately controlled before starting ZEJULA. Monitor
blood pressure monthly for the first year and periodically
thereafter during treatment with ZEJULA. ZEJULA should be
discontinued in case of hypertensive crisis or if medically
significant hypertension cannot be adequately controlled with
antihypertensive therapy.
Based on its mechanism of action, ZEJULA can
cause fetal harm. Advise females of reproductive potential of
the possible risk to a fetus and to use effective contraception
during treatment and for six months after receiving the final dose.
Because of the potential for serious adverse reactions in breastfed
infants from ZEJULA, advise a lactating woman not to breastfeed
during treatment with ZEJULA and for one month after receiving the
final dose.
In clinical studies, the most common adverse
reactions included: thrombocytopenia, anemia, neutropenia, nausea,
constipation, vomiting, abdominal pain, diarrhea, dyspepsia,
urinary tract infection, fatigue/asthenia, decreased appetite,
headache, dizziness, dysgeusia, palpitations, insomnia,
nasopharyngitis, dyspnea, cough, and hypertension.
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.
Forward Looking StatementsTo
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 commercial launch
efforts, 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 associated with
timing for successful ZEJULA commercial launch in specific
European countries, competition, risks related to pricing and
reimbursement, risks related to manufacturing and supply, risks
related to intellectual property, and other risks and uncertainties
that could affect the availability or commercial potential of
ZEJULA in Europe. 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2017.
Global Media & Investor
Contact:Jennifer DavisVice President, Corporate
Communications & Investor Relations+1.781.325.1116 or
jdavis@tesarobio.com
International Media
Contact:Shannon AltimariHead of Corporate Affairs,
International +41 (0) 41 588 08 68 or
saltimari@tesarobio.com
___________________________________
1 Wang J et al. The Exposure-Response Relationship of Niraparib
in Patients with gBRCAmut and Non-gBRCAmut: Results from the
ENGOT-OV16/NOVA Trial. ESMO; 2017 Sep 8-12; Madrid, Spain.
2 World Cancer Research Fund International.
http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/ovarian-cancer-statistics
(Last accessed 12 December 2017)
3 EUCAN
http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2
(Last accessed 12 December 2017)
4 ENGAGe, Ovarian Cancer Fact Sheet.
https://engage.esgo.org/media/2017/08/ENGAGe_What_is_ovarian_cancer_en_V01.pdf
(Last accessed 12 December 2017)
5 Lorusso, D., Mancini, M., Di Rocco, R., Fontanelli, R., &
Raspagliesi, F. (2012). The role of secondary surgery in recurrent
ovarian cancer. International Journal of Surgical Oncology
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