Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food
and Drug Administration (FDA) posted briefing materials in advance of
the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss
accelerated approval of the New Drug Application (NDA) for rociletinib,
an investigational therapy for the treatment of patients with mutant
epidermal growth factor receptor (EGFR) non-small cell lung cancer
(NSCLC) who have been previously treated with an EGFR-targeted therapy
and have the T790M mutation.
The ODAC meeting is scheduled to take place on April 12, 2016 from 8:30
a.m. ET to 1 p.m. ET. Briefing materials and webcast information can be
found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm494781.htm.
The FDA has set a target action date of June 28, 2016 for rociletinib
under the Prescription Drug User Fee Act (PDUFA).
About T790M-Positive Mutant EGFR NSCLC
Lung cancer is the second most common cancer in the United States, with
more than 200,000 new cases each year, and is the leading cause of
cancer-related death. NSCLC accounts for almost 85 percent of lung
cancers, and the five-year survival rate in locally advanced and
metastatic patients is 27 and four percent, respectively.
Approximately 10-15 percent of patients with NSCLC in the United States
have the EGFR mutation. While the majority of these patients will
respond to treatment with first- or second-generation EGFR-targeted
tyrosine kinase inhibitors (TKIs), most patients will eventually develop
acquired resistance to these therapies, predominantly due to the primary
resistance mutation, T790M.
About Rociletinib
Rociletinib is the company’s novel, oral, targeted covalent
(irreversible) mutant-selective inhibitor of EGFR in development for the
treatment of NSCLC in patients with initial activating EGFR mutations,
as well as the dominant resistance mutation T790M. Data from both the
pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the
basis for the U.S. and EU regulatory submissions for the treatment of
advanced mutant EGFR T790M-positive lung cancer. Rociletinib was granted
Breakthrough Therapy designation by the FDA in May 2014.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the United States, Europe and additional international
markets. Clovis Oncology targets development programs 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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