Spectrum Pharmaceuticals Inc. (SPPI) on Friday after the bell announced that it received approval from the U.S. Food and Drug Administration for expanded use of Fusilev in patients with advanced metastatic colorectal cancer. This new indication of Fusilev where it will be used in combination with 5-fluorouracil supplements the original 2008 FDA approval of the drug.
In 2008, Fusilev was approved by the regulatory agency and is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists.
Fusilev, which generated sales of $7.7 million in 2008, logged improved sales in the successive years - fetching $12.5 million in 2009 and $32 million in 2010. The FDA approval of Fusilev in the treatment of colorectal cancer could represent a significant growth catalyst, said Rajesh Shrotriya, Chairman, Chief Executive Officer, and President of Spectrum Pharma.
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 U.S, with approximately 141,210 new cases and 49,380 deaths expected in 2011.
Fusilev, under various trade names, is marketed 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.
SPPI closed Friday's trading at $9, down 13% on a volume of 7.4 million shares.
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