FDA Advisory Committee Votes that Qapzola™ (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo
September 14 2016 - 1:06PM
Business Wire
The FDA is Expected to Make a Final Decision by
PDUFA Date of December 11, 2016
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology,
announced today that the U.S. Food and Drug Administration (FDA)
Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola for
immediate intravesical instillation post-transurethral resection of
bladder tumors (post-TURBT) has not shown substantial evidence of a
treatment effect over placebo in patients with non-muscle invasive
bladder cancer (NMIBC).
The committee recommendation is not binding on the FDA,
which makes the final decision on approval. The Prescription Drug
User Fee Act (PDUFA) date for the Qapzola NDA is December 11,
2016.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
currently markets six hematology/oncology drugs, and has three
drugs in advanced stages of clinical development that have the
potential to transform the Company. Spectrum's strong track record
for in-licensing and acquiring differentiated drugs, and expertise
in clinical development have generated a robust, diversified, and
growing pipeline of product candidates in advanced-stage Phase 2
and Phase 3 studies. More information on Spectrum is available
at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to Spectrum’s business and its future,
including certain company milestones, Spectrum's ability to
identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, the timing
and results of FDA decisions, and any statements that relate to the
intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that Spectrum’s existing and new drug candidates may not prove safe
or effective, the possibility that our existing and new
applications to the FDA and other regulatory agencies may not
receive approval in a timely manner or at all, the possibility that
our existing and new drug candidates, if approved, may not be more
effective, safer or more cost efficient than competing drugs, the
possibility that our efforts to acquire or in-license and develop
additional drug candidates may fail, our dependence on third
parties for clinical trials, manufacturing, distribution and
quality control and other risks that are described in further
detail in the Company's reports filed with the Securities and
Exchange Commission. The Company does not plan to update any such
forward-looking statements and expressly disclaims any duty to
update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of
Spectrum Pharmaceuticals, Inc. and its affiliate. REDEFINING CANCER
CARE™, Qapzola™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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version on businesswire.com: http://www.businesswire.com/news/home/20160914006132/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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