FDA Approves FUSILEV® for Use in Patients with Colorectal Cancer
-
Colorectal Cancer is the Third Most Common Cancer in the United
States
-
There are Approximately 140,000 New Cases and 50,000 Deaths Annually
-
Ex-U.S. Sales of Levoleucovorin Are Approximately $180 Million
Annually
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FUSILEV® Sales Exceeded $34M in the First
Quarter of 2011, Resulting in a Second Consecutive Profitable Quarter
IRVINE, Calif.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in oncology, received approval from the U.S. Food and Drug
Administration (FDA) on April 29, 2011, for the use of FUSILEV®
(levoleucovorin) in combination with 5-fluorouracil in the palliative
treatment of patients with advanced metastatic colorectal cancer. This
new, expanded indication supplements the original 2008 FDA approval of
FUSILEV.
"We are pleased that the FDA has approved FUSILEV for use in colorectal
cancer," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive
Officer, and President of Spectrum Pharmaceuticals. "Although the NCCN
Guidelines in the United States already recommend levoleucovorin in the
treatment of colorectal cancer patients, we could not promote FUSILEV
for this indication until now. We believe that the FDA approval of
FUSILEV in the treatment of colorectal cancer could represent a
significant growth catalyst for Spectrum. In the United States, more
than 90% of its clinical use is for the treatment of patients with
colorectal cancer. FUSILEV, under various trade names, has been
available in Europe and Japan primarily by Wyeth, Sanofi-Aventis, and
Takeda Pharmaceuticals. It is estimated that ex-U.S. sales of FUSILEV
are in excess of $180 million a year."
According to the American Cancer Society, colorectal cancer is the third
most commonly diagnosed cancer and the third leading cause of cancer
death in both men and women in the US, with approximately 141,210 new
cases and 49,380 deaths expected in 2011.
About FUSILEV®
(levoleucovorin)
FUSILEV, a novel folate analog, is now approved as a ready-to-use
(FUSILEV Injection) solution in 175 mg and 250 mg vials, and as
freeze-dried powder (FUSILEV for Injection) in 50 mg vials. FUSILEV is
indicated for use in combination with 5-fluorouracil in the palliative
treatment of patients with advanced metastatic colorectal cancer.
FUSILEV is also indicated for rescue after high-dose methotrexate
therapy in osteosarcoma. FUSILEV is also indicated to diminish the
toxicity and counteract the effects of impaired methotrexate elimination
and of inadvertent overdosage of folic acid antagonists. FUSILEV, under
various trade names, is marketed outside the United States by Wyeth,
Sanofi-Aventis, and Takeda.
Important FUSILEV®
(levoleucovorin) Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic
reactions attributed to folic acid or folinic acid. Due to calcium
content, no more than 16-mL (160-mg) of levoleucovorin solution should
be injected intravenously per minute. FUSILEV enhances the cyto-toxicity
of fluorouracil. Concomitant use of d,l-leucovorin with
trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV
patients was associated with increased rates of treatment failure in a
placebo-controlled study. Allergic reactions were reported in patients
receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%)
were reported in patients receiving FUSILEV as rescue after high dose
methotrexate therapy. The most common adverse reactions (>50%) in
patients with advanced colorectal cancer receiving FUSILEV in
combination with 5-fluorouracil were diarrhea, nausea and stomatitis.
FUSILEV may counteract the antiepileptic effect of phenobarbital,
phenytoin and primidone, and increase the frequency of seizures in
susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully
integrated commercial and drug development operations with a primary
focus in oncology. The Company's strategy is comprised of acquiring,
developing and commercializing a broad and diverse pipeline of
late-stage clinical and commercial products. The Company markets two
oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and
belinostat, in late stage development along with a diversified pipeline
of novel drug candidates. The Company has assembled an integrated
in-house scientific team, including clinical development, medical
research, regulatory affairs, biostatistics and data management,
formulation development, and has established a commercial infrastructure
for the marketing of its drug products. The Company also leverages the
expertise of its worldwide partners to assist in the execution of its
strategy. For more information, please visit the Company's website 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 include but are not limited to statements that relate
to our 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, 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 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.®, ZEVALIN®,
and FUSILEV® are registered trademarks of
Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the
Spectrum Pharmaceutical logos are trademarks owned by Spectrum
Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights
Reserved.
Spectrum Pharmaceuticals
Paul Arndt, 949-788-6700 x 216
Senior
Manager, Investor Relations
Source: Spectrum Pharmaceuticals
News Provided by Acquire Media
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