Healthcare Industry News: Methotrexate
News Release - October 31, 2008
Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for FUSILEV(TM) in Colorectal CancerIRVINE, Calif.--(HSMN NewsFeed)--Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI ) today announced that it has filed with the FDA the supplemental NDA for FUSILEV™ (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. FUSILEV is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.
“Ninety percent of the more than 500 million milligrams of leucovorin used in the United States is for colorectal cancer,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Assuming the FDA accepts the filing and completes the standard 10-month review cycle, we would expect a complete response late in the third or early in the fourth quarter of 2009. We continue to expect our sales, under the currently approved indications, to ramp up slowly until the full range of indications and formulations are approved.”
Earlier this year, the Company completed its filing of an amendment to the New Drug Application (NDA) for FUSILEV™ Tablets. The Oncologic Drugs Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose Methotrexate.
About FUSILEV (levoleucovorin) for injection
FUSILEV, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV rescue is indicated 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 (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.
Important FUSILEV (levoleucovorin) for injection 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 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. 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
We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus, and; leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our 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 its portfolio of drug candidates, the safety and efficacy of FUSILEV™, that assuming the FDA accepts the filing and completes the standard 10-month review cycle, we would expect a complete response late in the third or early in the fourth quarter of 2009, that we expect our sales, under the currently approved indications, to ramp up slowly until the full range of indications and formulations are approved, the Company's promising pipeline, 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.
FUSILEV ™, SPECTRUM PHARMACEUTICALS, INC.™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners.
© 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Source: Spectrum Pharmaceuticals
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