Monday, October 02, 2006

Rituxan Receives Expanded FDA Approval

Genentech and Biogen Idec's Rituxan Gets Approval for Addition Non-Hodgkins Lymphoma Treatment

NEW YORK-- Drug developers Genentech Inc. and Biogen Idec Inc. said the Food and Drug Administration approved two new uses for Rituxan, covering two varieties of non-Hodgkins lymphoma.
The drug was first approved in 1997 to treat another form of non-Hodgkins lymphoma. Cambridge, Mass.-based Biogen developed the drug, which is co-marketed in the United States with South San Francisco, Calif.-based Genentech.

The first new indication is for Rituxan as part of a combination with chemotherapy as a first-line treatment for previously untreated patients with the follicular form of the blood cancer. The second indication deals with the drug as a second-line treatment in patients with a stable disease or after achieving a complete response following initial treatment with chemotherapy.

In February, the drug was approved as a first line treatment, in combination with chemotherapy, for patients with diffuse large B-Cell lymphoma. It is also being studied for use as a multiple sclerosis treatment.

Shares of Genentech rose $1.81, or 2.2 percent, to $84.51 on the New York Stock Exchange in midday trading. The stock has traded between $75.58 and $100.20 over the last 52 weeks. Shares of Biogen rose 11 cents to $44.79 on the Nasdaq.


Remember that rituxan is a humanized monoclonal antibody to a specific B cell antigen. When it binds to B cells, it triggers the patients immune system to see those cells as foreign and initials a cascade termed ADCC or antibody dependent cellular cytotoxicity. Think of a donut with toothpicks sticking out of it, the toothpicks are the antibodies which recruit the killer cells.

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