New Approvals for Rituxan

The FDA clears the drug for CD20-positive, B-cell non-Hodgkin's lymphoma in patients who haven't received prior treatments.
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Genentech

(DNA)

and

Biogen Idec

(BIIB) - Get Report

received two new regulatory approvals covering the blood cancer drug Rituxan.

The Food and Drug Administration cleared Rituxan to treat CD20-positive, B-cell non-Hodgkin's lymphoma in patients who haven't received any prior treatments for the disease, in combination with a chemotherapy regimen consisting of cyclophosphamide, vincristine and prednisolone.

The drug may also be used to treat patients with low-grade non-Hodgkin's lymphoma whose disease has responded or stabilized after treatment with the chemo.

"Nearly 10 years after Rituxan's initial approval, these new indications highlight the clinical benefit of Rituxan as part of first-line therapy for the treatment of low-grade or follicular non-Hodgkin's lymphoma, providing patients additional options to fight this chronic disease," said Dr. Hal Barron, Genentech's chief medical officer.

In 1997, Rituxan was approved for patients with low-grade or follicular CD20-positive, B-cell non-Hodgkin's lymphoma whose disease didn't respond to a prior treatment or worsened following treatment.

This past February, Rituxan in combination with another chemo regimen was approved as a first option for patients with diffuse large B-cell lymphoma.