Submission based on results from two large, positive pivotal trials
Both pivotal trials successfully met their primary endpoint and all
ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor
(G-CSF) that utilizes a proprietary platform technology to maximize
the pharmacological activity of G-CSF
HENDERSON, Nev.--(BUSINESS WIRE)--Dec. 27, 2018--
Spectrum Pharmaceuticals, Inc. (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
company submitted a Biologics License Application (BLA) with the U.S.
Food and Drug Administration (FDA) for ROLONTIS®
“ROLONTIS is an important and significant future growth driver for our
company,” said Joe Turgeon, President and CEO of Spectrum
Pharmaceuticals. “Today’s milestone brings us one step closer to
bringing the first novel G-CSF to healthcare providers in over 15 years
in a large market that is familiar to Spectrum.”
The BLA for ROLONTIS is supported by data from two identically designed
Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety
and efficacy of ROLONTIS in 643 early-stage breast cancer patients for
the treatment of neutropenia due to myelosuppressive cytoxic
chemotherapy. The study ADVANCE was conducted under a special protocol
assessment (SPA) with the Agency. In both studies, ROLONTIS demonstrated
the pre-specified hypothesis of non-inferiority (NI) in Duration of
Severe Neutropenia (DSN) and a similar safety profile to pegfilgrastim.
ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN
across all 4 cycles (all NI p<0.0001) in both studies.
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 seven
hematology/oncology drugs, and has an advanced stage pipeline that has
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.® and ROLONTIS®are registered trademark of Spectrum Pharmaceuticals, Inc. and its
affiliate. 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.
© 2018 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com: https://www.businesswire.com/news/home/20181227005058/en/
Source: Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations