(RTTNews) - Wednesday, biotechnology company Genentech Inc., a unit of Roche Hldg Ltd (RHHBY.PK), and Biogen Idec (BIIB: News ) said that the FDA issued a complete response on the companies' applications for Rituxan plus fludarabine and cyclophosphamide for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia.

The FDA has not requested any new data to complete its review of these applications.

Genentech and Biogen Idec said they will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.

According to the American Cancer Society, CLL is the most common adult leukemia, accounting for one-third of all leukemia in the United States. Nearly 90,000 Americans are living with CLL and expected to diagnosed more than 15,000 new cases this year. The disease is a slow-growing disorder that occurs when too many abnormal white blood cells are found in the blood and bone marrow, making it difficult for the body to fight infection.

The company noted that these applications are based on data from two Phase III studies, CLL8 and REACH. Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated, while REACH was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated.
Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular as a single agent and it was approved in the European Union under the trade name MabThera in 1998.

BIIB closed Wednesday's regular trading at $46.16 up $0.11 or 0.24% on a volume of 2.593 million shares on the Nasdaq and in the after hours trading the stock price decreased to $46.14 down $0.02 or 0.04%.

To receive FREE breaking news email alerts for Biogen Idec and others in your portfolio

by RTT Staff Writer

For comments and feedback: contact editorial@rttnews.com