Spectrum Pharmaceuticals Announces That FDA Has Accepted Fusilev sNDA for Colorectal Cancer Indication
IRVINE, Calif.--(BUSINESS WIRE)--Mar 26, 2009 - Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) announced today that it received notification that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009.
The FDA approved Fusilev on March 7, 2008 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. In December 2008, Fusilev was listed in the National Comprehensive Cancer Network® (NCCN) Drugs and Biologic Compendium to be used in combination with high-dose methotrexate for the treatment of bone cancer (osteosarcoma and dedifferentiated chrondrosarcoma), and the NCCN Clinical Practice Guidelines in Oncology in Colon Cancer and Rectal Cancer were updated to reflect that Fusilev is available in the United States.
About Fusilev (levoleucovorin) for Injection
Fusilev, a novel folate analog, is available in vials as 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.
Full prescribing information can be found at www.fusilev.com.
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.
World-renowned experts from NCCN Member Institutions diagnose and treat patients with a broad spectrum of cancers and are recognized for dealing with complex, aggressive, or rare cancers. More than 160,000 new patients receive cancer care at NCCN Member Institutions over the course of any year. NCCN Member Institutions pioneered the concept of the multidisciplinary team approach to patient care and lead the fight against cancer as they integrate programs in patient care, research, and education. Our programs offer access to expert physicians, superior treatment, and quality and safety initiatives that continuously improve the effectiveness and efficiency of cancer care. Thirty-seven Nobel Prize winners have served on the faculties of NCCN Member Institutions.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's 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 Spectrum's website at http://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 a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of Fusilev 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. Information regarding NCCN has been obtained from NCCN's website and not independently verified by Spectrum.
SPECTRUM PHARMACEUTICALS, INC. ® is a registered trademark owned by Spectrum Pharmaceuticals, Inc. Fusilev, TURNING INSIGHTS INTO HOPE, and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact: Spectrum Pharmaceuticals, Inc.
SVP & Chief Business Officer
Manager, Investor Relations
Posted: March 2009