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Celgene-Roche combo therapy wins FDA approval to treat 2 blood cancer subtypes

The U.S. Food and Drug Administration approved a combination therapy including Celgene Corp.'s Revlimid to treat two types of blood cancer.

The company's Revlimid, or lenalidomide, can be used in combination with rituximab — sold by Roche Holding AG as Rituxan — to treat patients with follicular lymphoma and marginal zone lymphoma whose disease had returned or did not respond to treatment.

Follicular lymphoma is a type of cancer that develops when the body makes abnormal versions of a type of white blood cell called B lymphocytes, or B cells, which help protect the body against bacteria or viruses by making proteins called antibodies. Marginal zone lymphomas are those that develop in the marginal zone or edge of the lymphoid tissue where B cells are located.

The Revlimid-rituximab treatment is the first FDA-approved combination regimen for patients with these indolent, or slow growing, forms of non-Hodgkin's lymphoma that does not include chemotherapy.

The FDA approval is based on results from a 358-patient phase 3 study, named Augment, which showed that the drug combination helped patients in the late-stage trial live longer while keeping the diseases at bay.

Results from the trial showed that the Revlimid-rituximab combination helped patients live for a median of 39.4 months while remaining free of the disease. In comparison, median progression-free survival for patients who received a combination of rituximab and placebo was 14.1 months.

The European Medicines Agency is reviewing the marketing application for the Revlimid-rituximab combination to treat this type of follicular lymphoma and marginal zone lymphoma, according to a May 28 news release.

Celgene has also submitted an application with the Japanese Pharmaceuticals and Medical Devices Agency to gain expanded approval for the drug combination to treat indolent B cell non-Hodgkin's lymphoma that had returned or did not respond to treatment.