Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved, after a Priority Review, two additional uses for Rituxan(R) (Rituximab) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). One new indication for Rituxan is for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
“The goal of treating low-grade or follicular NHL, a chronic cancer marked by multiple recurrences, is to delay disease progression for as long as possible,” said Howard Hochster, M.D., Professor of Medicine and Clinical Pharmacology, New York University School of Medicine and Cancer Institute. “These approvals enable doctors and patients to select among different treatment options with Rituxan in the front-line setting. As we demonstrated in the Eastern Cooperative Oncology Group trial, the use of extended Rituxan dosing following induction CVP chemotherapy in patients who reached stable disease or better has been shown to decrease the risk of disease progression, relapse or death.”
In February 2006, Rituxan in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy was approved as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Rituxan was approved in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD20- positive, B-cell NHL.
“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 Hal Barron M.D., Genentech senior vice president, development and chief medical officer. “The approvals are the result of an extraordinary collaboration between Biogen Idec, Genentech, the Eastern Cooperative Oncology Group, clinical investigators, the FDA, and most importantly, the patients who participated in the clinical trials.”
“These approvals further illustrate our commitment to optimizing treatment for patients with B-cell-related diseases,” said Arturo Molina, M.D., Biogen.