Rituxan Combo Approved for CLL

Genentech and Biogen Idec received FDA approval of Rituxan in combination with fludarabine and cyclophosphamide (FC) for people with previously treated/untreated CD20-positive chronic lymphocytic leukemia (CLL).

CLL is the most common form of adult leukemia and is a slow-growing cancer that occurs when abnormal or malignant white blood cells are found in the blood and bone marrow. Since the disease is considered incurable, the treatment aims to increase progression-free survival.

“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, M.D., executive vice president, Global Development and chief medical officer, Roche and Genentech. “This approval provides an important option and new hope to the many people with this incurable cancer.”

“This approval in CLL reinforces the importance of Rituxan in hematologic cancers,” said Greg Reyes, M.D., Ph.D., senior vice president, Oncology R&D, Biogen Idec. “We are very pleased that Rituxan, either alone or in combination, has now achieved its fifth approval for the most common forms of non-Hodgkin’s lymphoma and adult leukemia.”