Spectrum Pharmaceuticals Announces Results of FDA Meeting Regarding FUSILEV® sNDA under Review for Advanced Metastatic Color...
January 25 2010 - 7:00AM
Business Wire
Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage
biotechnology company with a primary focus in oncology, today
announced that it has met with the FDA regarding it’s supplemental
New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for
injection for the treatment of patients with advanced metastatic
colorectal cancer. In October 2009, the FDA issued a Complete
Response letter regarding its sNDA for FUSILEV.
The FDA requested additional data which the Company expects to
submit in the third quarter of 2010. The FDA did not request any
additional efficacy studies.
“We are very encouraged by the collaborative relationship and
straightforward requirements for approval posed to us by the FDA,”
said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer,
and President of Spectrum Pharmaceuticals. “We currently expect to
provide the FDA with the additional data they require to complete
their review of FUSILEV for the treatment of advanced metastatic
colorectal cancer in the third quarter.”
About FUSILEV® (levoleucovorin) for
Injection
FUSILEV, a novel folate analog, is available in vials as
freeze-dried powder. FUSILEV rescue is also indicated after
high-dose methotrexate therapy in osteosarcoma. Additionally,
FUSILEV is indicated to diminish the toxicity and counteract the
effects of impaired methotrexate elimination and of inadvertent
overdosage of folic acid antagonists. FUSILEV has been marketed
outside the United States by Wyeth, Sanofi-Aventis, Takeda, and
others for more than 10 years.
Full prescribing information can be found at
www.FUSILEV.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology
company with a focus in oncology. The Company’s strategy is
comprised of acquiring and developing a broad and diverse pipeline
of late-stage clinical and commercial products; establishing a
commercial organization for its approved drugs; continuing to build
a team with people who have demonstrated skills, passion,
commitment and have a track record of success in its areas of
focus; and, leveraging the expertise of partners around the world
to assist it in the execution of its strategy. For more
information, please visit the Company’s website at
www.sppirx.com.
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 include
but are not limited to statements that relate to Spectrum’s
business and its future, Spectrum's ability to identify, acquire,
develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, establishing a
commercial organization for Spectrum’s approved drugs, continuing
to build Spectrum’s team, leveraging the expertise of partners
around the world to assist Spectrum in the execution of its
strategy, that we expect to submit the additional data in the third
quarter, 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 Spectrum’s existing and new drug candidates may
not receive approval from the FDA, and other regulatory agencies in
a timely manner or at all, the possibility that Spectrum’s existing
and new drug candidates, if approved, may not be more effective,
safer or more cost efficient than competing drugs, the possibility
that Spectrum’s efforts to acquire or in-license and develop
additional drug candidates may fail, Spectrum’s lack of significant
revenues, limited marketing experience, dependence on third parties
for clinical trials, manufacturing, distribution and quality
control and other risks that are described in further detail in
Spectrum’s reports filed with the Securities and Exchange
Commission. Spectrum does not plan to update any such
forward-looking statements and expressly disclaim any duty to
update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC. ® and Fusilev® are registered
trademarks of Spectrum, TURNING INSIGHTS INTO HOPE™ and the
Spectrum Pharmaceutical logos are trademarks owned by Spectrum
Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
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