- Clovis seeks U.S. approval for
rucaparib as maintenance therapy for women with recurrent ovarian
cancer who are platinum sensitive, and in complete or partial
response to platinum chemotherapy, with no requirement for
diagnostic testing
- Priority review granted based on
positive data from phase 3 ARIEL3 clinical trial in which rucaparib
significantly improved PFS in all ovarian cancer patient
populations studied
- FDA assigns PDUFA date of April 6,
2018
Clovis Oncology (NASDAQ: CLVS) announced today that the U.S.
Food and Drug Administration (FDA) has accepted the company’s
supplemental New Drug Application (sNDA) for rucaparib and granted
priority review status to the application with a Prescription Drug
User Fee Act (PDUFA) date of April 6, 2018. In October, Clovis
completed its sNDA submission for rucaparib as maintenance
treatment in patients with recurrent epithelial ovarian, fallopian
tube, or primary peritoneal cancer who are platinum sensitive, and
in a complete or partial response to platinum-based chemotherapy.
The Company is seeking approval for use of rucaparib for this
indication regardless of a patient’s BRCA mutation status.
“We are pleased that we continue to make significant progress
toward our goal of delivering rucaparib to a much broader
population of women with advanced ovarian cancer,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “We are particularly
encouraged by the FDA’s decision to grant priority review to the
application, which may allow us to make rucaparib available to
these women in a more expeditious manner.”
A priority review designation is granted to proposed medicines
that the FDA has determined have the potential, if approved, to
offer a significant improvement in the safety or effectiveness of
the treatment, prevention or diagnosis of a serious condition.
Priority designation shortens the review period from the standard
ten months to six months from the acceptance of the NDA.
The rucaparib sNDA was submitted to the FDA in October 2017 and
is based on data from the phase 3 ARIEL3 clinical trial. ARIEL3 is
a double-blind, placebo-controlled trial of rucaparib that enrolled
564 women with platinum-sensitive, high-grade ovarian, fallopian
tube, or primary peritoneal cancer. The primary efficacy analysis
evaluated three prospectively defined molecular sub-groups in a
step-down manner: 1) BRCA mutant 2) HRD-positive; and, finally, 3)
the intent-to-treat population, or all patients treated in
ARIEL3.
Clovis announced positive topline results from the ARIEL3
clinical trial in June 2017. Additional data from the trial were
presented at the 2017 European Society for Medical Oncology (ESMO)
Annual Conference in Madrid, Spain,1 and subsequently published in
The Lancet.2
Clovis intends to file a variation to the Marketing
Authorization Application (MAA) in Europe in early 2018 for the
maintenance indication, contingent on a potential approval in
Europe for the ovarian cancer treatment indication.
About the ARIEL3 Clinical Trial
The ARIEL3 pivotal study of rucaparib is a confirmatory
randomized, double-blind study comparing the effects of rucaparib
against placebo to evaluate whether rucaparib given as a
maintenance treatment to platinum-sensitive ovarian cancer patients
can extend the period of time for which the disease is controlled
after a complete or partial response to platinum-based
chemotherapy. The study enrolled 564 patients with high-grade
epithelial ovarian, fallopian tube or primary peritoneal cancer. To
be eligible for the study, participants had to have received at
least two prior platinum-based treatment regimens, been sensitive
to the penultimate platinum regimen, and achieved a complete or
partial response to their most recent platinum-based regimen. There
were no genomic selection criteria for this study. Trial
participants were randomized 2:1 to receive 600 milligrams of
rucaparib twice daily (BID) or placebo.
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in ovarian cancer as well as several
additional solid tumor indications. During the fourth quarter of
2016, the Marketing Authorization Application (MAA) submission in
Europe for rucaparib in an ovarian cancer treatment indication was
submitted and accepted for review. A CHMP opinion is expected in
late 2017. In October 2017, Clovis Oncology submitted a
supplemental New Drug Application (sNDA) in the U.S. for a second
line or later maintenance treatment indication in ovarian cancer
based on the ARIEL3 data. In early 2018, Clovis plans to file a
variation to the MAA in Europe for the maintenance treatment
indication contingent on a potential approval for the ovarian
cancer treatment indication. Studies open for enrollment or under
consideration include ovarian, prostate, breast, gastroesophageal,
pancreatic, lung and bladder cancers. Clovis holds worldwide rights
for rucaparib.
About Rubraca® (rucaparib)
Rubraca is a PARP inhibitor indicated in the U.S. as monotherapy
for the treatment of patients with deleterious BRCA mutation
(germline and/or somatic) associated advanced ovarian cancer, who
have been treated with two or more chemotherapies, and selected for
therapy based on an FDA-approved companion diagnostic for Rubraca.
The indication for Rubraca is approved under the FDA’s accelerated
approval program based on objective response rate and duration of
response, and is based on results from two multicenter, single-arm,
open-label clinical trials. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in confirmatory trials. Please visit rubraca.com for more
information.
About Ovarian Cancer
According to the American Cancer Society, more than 22,400 women
will be diagnosed with ovarian cancer in the U.S. in 2017. There
are often no clearly identifiable initial symptoms, and in an
estimated 80 to 85 percent of ovarian cancer cases, the cancer has
spread to other parts of the body before a person is diagnosed and
can be treated. Ovarian cancer ranks fifth in cancer deaths and
causes more deaths than any other cancer of the female reproductive
system.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer
agents in the U.S., Europe and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners,
diagnostic tools intended to direct a compound in development to
the population that is most likely to benefit from its use. Clovis
Oncology is headquartered in Boulder, Colorado, and has additional
offices in San Francisco, California and Cambridge, UK. Please
visit clovisoncology.com for more information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
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.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our expectation
of timing for review and approval of the sNDA and submission,
review and approval of the MAA for rucaparib. Such forward-looking
statements involve substantial risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from that expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
uncertainties inherent in the clinical development programs for our
drug candidates, including the result of clinical trials, whether
future study results will be consistent with study findings
to-date, the corresponding development pathways of our companion
diagnostics, the timing of availability of data from our clinical
trials and the results of our clinical trials, the initiation,
enrollment and timing of our planned clinical trials, actions by
the FDA, the EMA or other regulatory authorities regarding
whether to approve drug applications that may be filed, as well as
their decisions that may affect drug labeling, pricing and
reimbursement, and other matters that could affect the availability
or commercial potential of our drug candidates or companion
diagnostics. Clovis Oncology does not undertake to update or
revise any forward-looking statements. A further description of
risks and uncertainties can be found in Clovis Oncology’s filings
with the Securities and Exchange Commission, including its Annual
Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
_________________________________________________________________________
1 Ledermann, J., MD. ARIEL3: A phase 3, randomised, double-blind
study of rucaparib vs placebo following response to platinum-based
chemotherapy for recurrent ovarian carcinoma (OC). Presented at
2017 European Society for Medical Oncology Congress in Spain,
Madrid. 8 September 2017.2 Coleman R, et al. Rucaparib maintenance
treatment for recurrent ovarian carcinoma after response to
platinum therapy (ARIEL3): a randomised, double-blind,
placebo-controlled, phase 3 trial. The Lancet. 12 September 2017.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32440-6/fulltext
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version on businesswire.com: http://www.businesswire.com/news/home/20171205006349/en/
Clovis OncologyInvestor Contacts:Anna Sussman,
303-625-5022asussman@clovisoncology.comorBreanna Burkart,
303-625-5023bburkart@clovisoncology.comorMedia Contacts:Lisa
Guiterman, 301-217-9353clovismedia@sambrown.comorChristy Curran,
615-414-8668clovismedia@sambrown.com
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