Clovis Oncology Announces Rucaparib Data Presentations at ESMO 2016 Congress
September 28 2016 - 7:55AM
Business Wire
- Data for rucaparib in the treatment of
advanced ovarian cancer to be highlighted in oral presentation
- U.S. Food and Drug Administration (FDA)
accepted accelerated approval application for review and granted
priority review status
- Prescription Drug User Fee Act (PDUFA)
date is February 23, 2017
- European Marketing Authorization
Application (MAA) planned in Q4 2016
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that data
from its rucaparib program in ovarian cancer will be presented at
the annual European Society for Medical Oncology (ESMO) 2016
Congress. ESMO will take place October 7-11, 2016 in Copenhagen,
Denmark. The data being presented comprise the primary efficacy and
safety data included in the New Drug Application (NDA) currently
under priority review with the FDA.
Rucaparib is the Company’s oral, potent, small molecule
inhibitor of PARP1, PARP2 and PARP3 currently being developed for
the treatment of advanced ovarian cancer, specifically in patients
with tumors with BRCA mutations and other DNA repair deficiencies
beyond BRCA (commonly referred to as homologous recombination
deficiencies, or HRD). Data from rucaparib studies are the subject
of one oral and one poster presentation at the conference:
Abstract 856O – Clinical activity of the poly(ADP-ribose)
polymerase (PARP) inhibitor rucaparib in patients (pts) with high
grade ovarian carcinoma (HGOC) and a BRCA mutation (BRCAmut):
Analysis of pooled data from Study 10 (parts 1, 2a, and 3) and
ARIEL2 (parts 1 and 2)
- Rebecca S. Kristeleit, PhD, The
University College London, Cancer Institute, London, United
Kingdom
- Friday, October 7 from 2:45pm-3:00pm
CEST
- Location: Oslo
Abstract 219TiP – Window study of the PARP inhibitor rucaparib
in patients with primary triple negative or BRCA1/2 related breast
cancer (RIO)
- Christy Toms, PhD, The Institute of
Cancer Research, Sutton, United Kingdom
- Monday, October 10 from 1:00pm-2:00pm
CEST
- Location: Hall E, Poster Board
#219
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed for advanced ovarian cancer.
Specifically, Clovis is developing rucaparib as monotherapy
treatment of advanced ovarian cancer in patients with deleterious
BRCA-mutated tumors inclusive of both germline and somatic BRCA
mutations (as detected by an FDA-approved test) who have been
treated with two or more chemotherapies. Rucaparib was granted
Breakthrough Therapy Designation for this proposed indication by
the FDA in April 2015. In August 2016, the FDA accepted Clovis’ New
Drug Application (NDA) submission for accelerated approval of
rucaparib and granted priority review status to the application
with a PDUFA date of February 23, 2017; and in September 2016, the
FDA notified Clovis that the Agency is not planning to hold an
advisory committee meeting to discuss the Company’s NDA for
rucaparib. The Company’s Marketing Authorization Application (MAA)
to the European Medicines Agency for the proposed treatment
indication for rucaparib is planned for Q4 2016.
Additionally, Clovis is developing rucaparib as maintenance
therapy in the ARIEL3 trial for ovarian cancer patients with tumors
with BRCA mutations and other DNA repair deficiencies beyond BRCA
(commonly referred to as homologous recombination deficiencies, or
HRD). Data from ARIEL3 are expected in Q4 2017, which is expected
to be followed by the submission of a supplemental NDA for a
second-line or later maintenance indication.
Rucaparib is also being explored in other solid tumor types with
BRCA and HRD populations, including breast, prostate and
gastroesophageal cancers.
Clovis holds worldwide rights for rucaparib.
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 aimed at specific
subsets of cancer populations, and simultaneously develops
diagnostic tools that direct a compound in development to the
population that is most likely to benefit from its use. Clovis
Oncology is headquartered in Boulder, Colorado.
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.
Such forward-looking statements involve substantial risks and
uncertainties that could cause our 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, the
uncertainties inherent in our clinical development programs for our
drug candidates, the corresponding development pathways of our
companion diagnostics, 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
regarding drug labeling, and other matters that could affect the
availability or commercial potential of our drug candidates or
companion diagnostics, including competitive developments. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160928005053/en/
Clovis Oncology, Inc.Breanna Burkart,
303-625-5023bburkart@clovisoncology.comorAnna Sussman,
303-625-5022asussman@clovisoncology.com
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