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Cancer Resources > Cancer News > 2007 > February

Biogen leukemia drug to get speedy FDA review

Last Updated: 2007-02-07 14:00:13 -0400 (Reuters Health)

BOSTON (Reuters) - Biogen Idec Inc. said on Wednesday that U.S. regulators will review its experimental leukemia drug on a speedy basis and grant it seven years of market exclusivity if approved.

Biogen said the drug, lumiliximab, has been granted "orphan drug" status as a treatment for chronic lymphocytic leukemia. The designation is typically given to drugs that treat small patient populations and helps protect them from competitors.

The U.S. Food and Drug Administration also granted the drug "Fast Track" status, which means the agency will accept clinical trial data on a rolling basis. That can cut in half the time needed for the FDA to decide whether to approve the drug.

Biogen said it has begun the last trial needed before approval. The trial will compare patients who take lumiliximab in combination with chemotherapy and Biogen's cancer drug Rituxan, with patients who take chemotherapy and Rituxan alone.

In December, the company presented data at the annual meeting of the American Society of Hematology showing that nearly 50 percent of patients taking lumiliximab in combination with chemotherapy and Rituxan had a complete disappearance of leukemia cells from their blood compared to about 25 percent of patients who took the chemotherapy/Rituxan therapy alone.

Lumiliximab is a monoclonal antibody that binds to a protein on the surface of malignant CLL cells called CD23. When the antibody binds to the protein it triggers cell death.

Cambridge, Massachusetts-based Biogen, which makes the multiple sclerosis drugs Avonex and Tysabri, said it expects to enroll about 276 patients in its late-stage lumiliximab trial, which will test patients who have relapsed or failed initial therapy.

CLL is a cancer that starts in white blood cells of the bone marrow, then invades the blood and can spread to the lymph nodes, spleen and other parts of the body.

About 77,000 Americans currently suffer from CLL and about 10,000 new cases are expected to occur in the United States this year, the company said.

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