HENDERSON, Nev.--(BUSINESS WIRE)--Mar. 15, 2019--
Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) announced today that
due to the U.S. Food and Drug Administration’s (FDA) request for
additional manufacturing-related information for ROLONTIS, the company
has voluntarily withdrawn its Biologics License Application (BLA).
Spectrum plans to resubmit a revised BLA as soon as possible.
The FDA did not cite concerns related to the pre-clinical and clinical
modules of the BLA or the need for additional clinical studies.
Spectrum’s decision to withdraw the BLA was the result of the company
needing more time to provide certain additional manufacturing-related
information, which was required before March 29, 2019, the day that the
FDA’s initial 60-day review period ends.
“We are continuing to have productive discussions with the FDA and will
deliver the additional information needed to support the
application,” said Joe Turgeon, President and CEO of Spectrum
Pharmaceuticals. “We remain confident in the ROLONTIS program and look
forward to a successful resubmission and its ultimate approval.”
ROLONTIS is being evaluated as a novel therapy for the management of
chemotherapy-induced neutropenia in patients undergoing myelosuppressive
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on
acquiring, developing, and commercializing novel and targeted drug
products, with a primary focus in hematology and oncology. Spectrum has
a strong track record of successfully executing across the
biopharmaceutical business model, from in-licensing and acquiring
differentiated drugs, clinically developing novel assets, successfully
gaining regulatory approvals and commercializing in a competitive
healthcare marketplace. Spectrum has a late-stage pipeline with novel
assets that serve areas of unmet need. This pipeline has the potential
to transform the company in the near future.
Forward-looking statement - Certain statements in this press release
may constitute “forward-looking statements” within the meaning of the
United States Private Securities Litigation Reform Act of 1995, as
amended to date. These forward-looking statements relate to a variety of
matters, including, without limitation, statements that relate to
Spectrum’s business and its future, including the timing ofthe
resubmission of the BLA for ROLONTIS, the timing and results of FDA
decisions, including with respect to the ROLONTIS BLA, the future
potential of Spectrum’s existing drug pipeline, Spectrum's ability to
identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, and other
statements that are not purely statements of historical fact. These
forward-looking statements are made on the basis of the current beliefs,
expectations and assumptions of the management of Spectrum and are
subject to significant risks and uncertainties that could cause actual
results to differ materially from what may be expressed or implied in
these forward-looking statements. Risks that could cause actual results
to differ include, but are not limited to, the uncertainties inherent in
new product development, including clinical trial results and additional
analysis of existing clinical data, Spectrum’s ability to gather and
analyze the manufacturing data requested by the FDA in connection with
the resubmission of the ROLONTIS BLA, the possibility that Spectrum’s
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 Spectrum’s existing and new drug candidates, including ROLONTIS,
may not ultimately prove to be safe or effective, 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 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.® and ROLONTIS®
are registered trademarks of Spectrum Pharmaceuticals, Inc. and
its affiliates. REDEFINING CANCER CARE™ and the Spectrum
Pharmaceuticals’ logos are trademarks owned by Spectrum Pharmaceuticals,
Inc. Any other trademarks are the property of their respective owners.
© 2019 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com: https://www.businesswire.com/news/home/20190315005110/en/
Source: Spectrum Pharmaceuticals, Inc.
Vice President, Strategic Planning & Investor Relations