Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Zevalin
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)--Jul. 5, 2009--
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
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.
Source: Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc.
Russell Skibsted, 949-788-6700 ext.
Sr. Vice President & Chief Business Officer
Arndt, 949-788-6700 ext. 216
Senior Manager, Investor Relations
Close window | Back to top