Genentech, Biogen receive FDA OK for Rituxan Plus CHOP for non-Hodgkin's lymphoma

By Lisa Kerner

Erie, Pa., Feb. 10 - Genentech, Inc. and Biogen Idec, Inc. said Friday that the Food and Drug Administration has approved Rituxan (Rituximab) for use in the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.

Rituxan has previously been approved as a single agent for use in relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma, according to a company news release.

Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells.

"Diffuse large B-cell lymphoma can be fatal within as little as six months to two years without aggressive treatment," Sandra J. Horning, M.D., chair, lymphoma group for the Eastern Cooperative Oncology Group, said in the release.

"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."

An estimated 360,000 Americans have non-Hodgkin's lymphoma and more than 58,000 new cases are diagnosed annually, the company said. Early diagnosis and treatment can improve chances of long-term survival. Of those diagnosed, about 50% have an aggressive form of the disease known as DLBCL.

The FDA approval was based on efficacy and safety data from three randomized, controlled, multicenter studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated (first-line) patients with DLBCL.

With two years of follow-up, more patients were alive in the Rituxan-containing versus control arms for each study.

The GELA trial was designed to evaluate the efficacy and safety of Rituxan in combination with induction CHOP chemotherapy in 399 patients 60 years of age or older with DLBCL. At five years, an estimated 58% of patients who received Rituxan plus chemotherapy were alive versus 46% of patients who received chemotherapy alone.

In the MInT trial, 95% of patients who received Rituxan in addition to chemotherapy survived two years versus 86% of patients who received chemotherapy alone. In the E4494 study of DLBCL patients age 60 years or older, 74% of patients who received Rituxan plus chemotherapy survived two years versus 63% who received chemotherapy alone.

"The best chance to achieve treatment success is in the first-line setting and these data demonstrate that first-line treatment with up to eight cycles of Rituxan plus chemotherapy resulted in a significant survival advantage in patients with diffuse large B-cell lymphoma," said Arturo Molina, M.D., Biogen Idec's acting head of Medical Research, Hematology/Oncology, in a news release.

Genentech is a biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. The company is based in South San Francisco.

Biogen, based in Cambridge, Mass., develops, manufactures and commercializes novel therapies.

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