The FDA is Expected to Make a Final Decision by PDUFA Date of
December 11, 2016
HENDERSON, Nev.--(BUSINESS WIRE)--
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
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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