Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for Beleodaq™ (belinostat) for Injection, a novel pan-H...
February 06 2014 - 7:00AM
Business Wire
- FDA grants Priority Review
Designation
- FDA decision date based on
PDUFA set for August 9, 2014
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations and a primary focus in Hematology and Oncology,
announced today that its New Drug Application (NDA) for Beleodaq, a
novel, pan-histone deacetylase (HDAC) inhibitor, has been accepted
for filing by the U.S. Food and Drug Administration (FDA). FDA
establishes review classification for this application as Priority
Review. The FDA has assigned a Prescription Drug User Fee Act
(PDUFA) action date of August 9, 2014. Spectrum is seeking FDA
approval of Beleodaq for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (R/R PTCL).
“The FDA’s acceptance of this NDA submission is another
important milestone in our strategy to bring Beleodaq to market,
and one step closer to the possible availability of more treatment
options to address the unmet medical need for patients with R/R
PTCL,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive
Officer, and President of Spectrum Pharmaceuticals. “The Priority
Review designation for the Beleodaq NDA acknowledges the potential
significant improvement in its safety or effectiveness for the
treatment for patients with the serious condition of R/R PTCLs when
compared to standard applications. Since approximately 70% of R/R
PTCL patients fail the currently approved treatments in the course
of their therapy, Beleodaq could be an important additional
treatment option for these patients. Importantly, several patients
treated with Beleodaq were able to go on to potentially curative
stem cell transplantation. We expect to use our existing sales
force to successfully launch Beleodaq if approved by the FDA.”
Beleodaq is differentiated from other HDAC inhibitors that
selectively inhibit a single class of HDAC enzymes by virtue of its
inhibition of all 3 classes of the zinc-dependent HDAC enzymes
(Class I, Class II and Class IV); this leads to different
alterations in histone and non-histone protein acetylation that, in
turn, could importantly influence chromatin accessibility, gene
transcription, and the clinical activity of this drug in different
cancer patients, including those who have developed drug-resistant
disease.
About Peripheral T-Cell Lymphoma
According to the Lymphoma Research Foundation
(www.lymphoma.org), lymphoma is the most common blood cancer.
Hodgkin's lymphoma and non-Hodgkin's lymphoma (NHL) are the two
main forms of lymphoma. Lymphoma occurs when lymphocytes, a type of
white blood cell, grow abnormally and accumulate in one or more
lymph nodes or lymphoid tissues. The body has two main types of
lymphocytes that can develop into lymphomas: B-lymphocytes
(B-cells) and T-lymphocytes (T-cells). PTCL comprises a group of
rare and aggressive NHLs that develop from mature T-cells. PTCL
accounts for approximately 10 to 15% of all NHL cases in the United
States.
About Beleodaq
Beleodaq is a pan-HDAC inhibitor being studied in multiple
clinical trials as a single agent or in combination with
chemotherapeutic agents for the treatment of various hematological
and solid cancers. Its anticancer effect is thought to be mediated
through multiple mechanisms of action, including the inhibition of
cell proliferation, induction of apoptosis (programmed cell death),
inhibition of angiogenesis, and the induction of differentiation.
Beleodaq has been shown to have activity in tumors that had become
resistant to anticancer agents such as the platinums, taxanes and
topoisomerase II inhibitors.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in oncology and hematology. Spectrum
and its affiliates market four oncology drugs — FUSILEV®
(levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate
injection), also marketed in the U.S.; ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights and MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) for intravenous infusion, for which the Company
has worldwide marketing rights. Spectrum's strong track record in
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 our business and its future, including
sales of Spectrum’s drug products, certain company milestones,
Spectrum's ability to identify, acquire, develop and commercialize
a broad and diverse pipeline of late-stage clinical and commercial
products, leveraging the expertise of partners and employees around
the world to assist us in the execution of our strategy, 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 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 lack of sustained
revenue history, our limited marketing experience, our customer
concentration, the possibility for fluctuations in customer orders,
evolving market dynamics, our dependence on third parties for
clinical trials, manufacturing, distribution, information 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.®, FUSILEV®, FOLOTYN®, ZEVALIN®
and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals,
Inc and its affiliates. BELEODAQ™, 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.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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