FDA OK's chronic lymphocytic leukemia drug

WASHINGTON, Feb. 22 (UPI) -- The U.S. Food and Drug Administration says it has approved Rituxan to treat certain patients with chronic lymphocytic leukemia.

Rituxan (rituximab) is intended to treat the slowly progressing blood and bone marrow cancer in patients beginning chemotherapy for the first time and those who have not responded to other cancer drugs, the FDA said.

"Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA's commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases," said Dr. Richard Pazdur, director of the federal agency's Office of Oncology Drug Products.

FDA approved Arzerra (ofatumumab) in October for patients whose cancer is no longer being controlled by other forms of chemotherapy and Treanda (bendamustine) in March 2008 for patients with CLL who had not received prior treatment.

Rituxan carries FDA boxed warnings for infusion reactions, rashes and sores of the skin and mouth; progressive multifocal leukoencephalopathy -- a brain infection that is generally fatal -- and tumor lysis syndrome, which results from the death of a large number of tumor cells within a short period of time.

Rituxan is manufactured by Genentech of San Francisco, a member of the Roche Group.