Spectrum says stronger Fusilev wins ok from FDA

Spectrum says stronger Fusilev wins ok from FDA

April 22nd, 2011 // 1:55 pm @

Spectrum Pharmaceuticals Inc. /quotes/comstock/15*!sppi/quotes/nls/sppi SPPI 0.00% on Thursday said it won U.S. Food and Drug Administration approval for its ready-to-use injection of Fusilev, a treatment that is a higher strength than the currently available formula.

Shares climbed 3.5% to $9.40 in recent trading.

Fusilev had already won FDA approval for patients with osteosarcoma, a common form of bone cancer, who are treated with the folic acid antagonist methotrexate. Fusilev’s therapy administers a high dose of methotrexate to kill more cancer cells while protecting the healthy cells.

Spectrum’s Fusilev has been marketed outside the U.S. by Pfizer Inc.’s (PFE) Wyeth, Sanofi-Aventis SA (SNY, SAN.FR) and others for more than 10 years. Fusilev’s revenue totaled $32 million in 2010, more than double the prior year.

The submission for the ready-to-use formulation of Fusilev was originally submitted in February in support of the treatment’s use in colorectal cancer, which is currently under review by the FDA, with a Prescription Drug User Fee Act action date of April 29.

Spectrum last month reported its fourth-quarter profit slid 56% as a year-earlier gained masked soaring revenue growth.


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