First Monoclonal Antibody OKed For Cancer In USA

30 July 1997

A monoclonal antibody developed by IDEC Pharmaceuticals and Genentech,called Rituxan (rituximab, previously code-named IDEC-C2B8), has been unanimously recommended for approval by the US Food and Drug Administration's Biological Response Modifiers Advisory Committee for the treatment of relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma.

Rituxan could be the first monoclonal antibody to be approved for the treatment of cancer, and "may represent a new approach to cancer treatment; it harnesses the body's immune system to focus on and destroy cancer cells," according to Antonio Grillo-Lopez, IDEC's senior vice president of medical and regulatory affairs.

In contrast to standard chemotherapy regimens, Rituxan has less serious side effects and takes less time to administer; it is given on an outpatient basis over a period of 22 days, with an infusion once a week for four weeks. This compares to a four-to-six-month chemotherapy regimen or high-dose radiation.

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