Rituxan gets nod of approval from FDA

ROCKVILLE, Md. The Food and Drug Administration has approved a drug made by Roche subsidiary Genentech and Biogen Idec as a treatment for the most common type of adult leukemia, the agency announced Thursday.

The FDA approved Rituxan (rituximab) for patients with chronic lymphocytic leukemia who are beginning chemotherapy for the first time and for those who have not responded to other CLL drugs. The drug is already used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and is the third drug to win FDA approval as a treatment for CLL, after the October 2009 approval of GlaxoSmithKline’s and Genmab’s Arzerra (ofatumumab) and the March 2008 approval of Cephalon’s Treanda (bendamustine hydrochloride).

“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” Roche and Genentech EVP global development and chief medical officer Hal Barron said in a statement. “This approval provides an important option and new hope to the many people with this incurable cancer.”

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