FDA approves rituxan to treat chronic lymphocytic leukaemia
The US Food and Drug Administration has approved Genentech\'s Rituxan (rituximab) to treat blood and bone marrow cancer.
The US Food and Drug Administration has approved Genentech's Rituxan (rituximab) to treat blood and bone marrow cancer.
Rituxan, discovered by Biogen Idec, is for patients with chronic lymphocytic leukaemia (CLL), who are beginning chemotherapy for the first time and for those who have not responded to other cancer drugs for CLL. It is administered with two other chemotherapy drugs, fludarabine and cyclophosphamide.
"Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening," said Hal Barron, chief medical officer, of Roche and Genentech.
CLL accounts for one-third of all leukemia cases in the US.
"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 Richard Pazdur, director, Office of Oncology Drug Products in the FDA's Centre for Drug Evaluation and Research.
The FDA approved Arzerra (ofatumumab) in October 2009 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.
