BOULDER, Colo.--(BUSINESS WIRE)--Mar. 23, 2018--
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an
early access program in Europe for rucaparib for treatment and as
maintenance therapy in recurrent ovarian cancer. The program will be
overseen and implemented by Caligor Coghlan, which specializes in early
access to medicines.
The program, to be known as the Rucaparib Access Program (RAP), will
enable participation from certain countries in Europe, where permitted
by applicable rules, procedures and regulatory authorities. The RAP
protocol allows for rucaparib treatment of an individual patient with
third-line or greater BRCA mutant epithelial, fallopian tube, or primary
peritoneal ovarian cancer who has platinum-sensitive disease and is
unable to tolerate further platinum-based chemotherapy or has
platinum-resistant disease and needs treatment with single agent
rucaparib. The RAP protocol will also provide access to rucaparib for
maintenance therapy of an individual patient with recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer who has received
at least two prior platinum-based treatment regimens, has
platinum-sensitive disease, and is in a complete or partial response to
the most recent platinum-based regimen. In all cases, the patient must
have a special clinical need that cannot be met by current licensed
available medicines. Patients must be ineligible for Clovis’
ARIEL4 clinical trial or unable to access a participating ARIEL4 site to
qualify for Clovis’ early access program.
Questions or inquiries regarding the RAP should be directed to rucaparibaccessEU@caligorrx.com.
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3
being developed in ovarian cancer as well as several additional solid
tumor indications. Studies open for enrollment or under consideration
include ovarian, prostate, breast, gastroesophageal, pancreatic, lung
and bladder cancers. Clovis holds worldwide rights for Rubraca.
In the United States, Rubraca is approved on an accelerated basis 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. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials. In December
2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s
supplemental New Drug Application (sNDA) for Rubraca for a second-line
or later maintenance treatment indication in ovarian cancer based on the
ARIEL3 data. The FDA granted Priority Review status to the application
with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018.
Rubraca is an unlicensed medical product outside of the U.S.
About Early Access Programs
Early Access Programs provide companies with a way to allow ethical
access to their pre-license/unlicensed medicines to help patients with
unmet medical needs. Access is provided in response to physician
requests, in a fully compliant manner, where no alternative treatment
options are available.
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
European Commission approval of rucaparib for the treatment indication
and the filing of a variation to the MA for a maintenance indication 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180323005344/en/
Source: Clovis Oncology, Inc.
Clovis Oncology, Inc.