Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Zevalin

Sun Jul 5, 2009 1:37pm EDT
 
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* FDA Requests Data From The FIT Study To Validate Subset Of sBLA Package
* Spectrum Will Provide All Data Requested By The FDA As Part Of Its Formal
Response By Wednesday, July 8th At The Latest
* FDA Request Does Not Involve New Clinical Studies or New Data Analyses
* ZEVALIN Is Currently FDA Approved and Marketed by Spectrum for Patients With
Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin`s Lymphoma,
Including Patients Who Have Rituximab-Refractory Follicular NHL

IRVINE, Calif.--(Business Wire)--
Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology
company with a focus in oncology, today announced that it has received a
Complete Response letter from the U.S. Food and Drug Administration (FDA)
regarding its supplemental Biologics License Application (sBLA) for ZEVALIN®
(ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin`s
Lymphoma (NHL) patients. The Prescription Drug User Fee Act (PDUFA) Action Date
for the ZEVALIN sBLA in the first-line consolidation setting was July 2, 2009.
ZEVALIN is currently FDA approved and marketed by Spectrum for the treatment of
patients with relapsed or refractory, low-grade or follicular B-cell NHL,
including patients who have rituximab-refractory follicular NHL. 

The FDA requested the Company to submit data files from the FIT study to support
and verify a subset of the data that are currently under review to support the
proposed labeling. Importantly: 

1) No additional clinical studies have been requested; 

2) The additional data requested do not involve new data analyses; 

3) The Company plans to formally respond to the FDA`s requests by this
Wednesday, July 8, 2009. 

Spectrum is confident that the data it will submit will satisfy the requirements
of the Complete Response letter, and, at this time, continues to expect a
favorable regulatory decision. 

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.spectrumpharm.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 include but are not limited to
statements that relate to our 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 our approved drugs, continuing to build our team, leveraging
the expertise of partners around the world to assist us in the execution of our
strategy, the safety and efficacy of ZEVALIN, that we will submit our response
by this Wednesday, July 8, 2009, that we will receive a favorable regulatory
decision, 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 our existing and new drug candidates, may not prove safe or
effective, the possibility that our 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 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 lack of revenues, our limited marketing
experience, 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. We do 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.  is a registered trademark of Spectrum, TURNING
INSIGHTS INTO HOPE and the Spectrum Pharmaceutical logos are trademarks owned by
Spectrum Pharmaceuticals, Inc. ZEVALIN is a registered trademark of RIT
Oncology, LLC, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc.

© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.



Spectrum Pharmaceuticals, Inc.
Russell Skibsted, 949-788-6700 ext. 234
Sr. Vice President & Chief Business Officer
Paul Arndt, 949-788-6700 ext. 216
Senior Manager, Investor Relations 



Copyright Business Wire 2009

 

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