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Rituxan Gets Added Clearance

The drug is now approved to treat diffuse large B-cell lymphoma.




Biogen Idec

(BIIB) - Get Free Report

have received an additional marketing clearance for the lymphoma drug Rituxan.

The Food and Drug Administration approved the drug for an aggressive type of the disease called diffuse large B-cell lymphoma, which attacks a specific type of immune-system cells. Rituxan is already approved to treat low-grade non-Hodgkin's lymphoma.

The FDA approval, announced Friday, was based on efficacy and safety data involving 1,854 previously untreated patients comparing Rituxan in combination with a chemotherapy regimen dubbed "CHOP," or a similar treatment, with results in patients receiving chemo alone. CHOP chemothrapy consists of treatment with cyclophosphamide, doxorubicin, vincristine and prednisone.

In one study, more patients receiving Rituxan were alive after two years than those not receiving the drug. In a study with five years of follow-up, the survival rate for the Rituxan-CHOP group was 47% higher than those receiving CHOP alone.

Diffuse large B-cell lymphoma can be fatal in as few as six months, according to the Eastern Cooperative Oncology Group, one of the largest clinical cancer research groups in the U.S.

"With this approval, Rituxan in combination with chemotherapy becomes the first FDA-approved treatment to improve survival for patients with this type of non-Hodgkin's lymphoma since the introduction of the CHOP chemotherapeutic regimen more than 25 years ago," said Dr. Sandra Horning, chair of research group's lymphoma division.

About 90% of patients with aggressive non-Hodgkin's lymphoma have the B-cell type, while the disease in the remaining patients affects T-cells, according to Genentech.

Genentech's shares were 1.2% lower to $82.49 Monday after an announcement that recruitment for an unrelated trial of its cancer drug Avastin was

suspended. Biogen Idec's shares were down 1.3% to $43.70.