FDA Approves Two New Indications For Rituxan(R) In Patients With Non-Hodgkin's Lymphoma
"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.
Idec's Senior Director, Hematology/Oncology, Medical Research/Clinical Development.
Clinical Studies
The FDA approval of Rituxan as a first-line treatment in previously- untreated patients with follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy is based on data from a Phase III, randomized, controlled study of 322 patients. The study evaluated the first-line use of Rituxan in combination with CVP chemotherapy (R-CVP) versus CVP chemotherapy alone. All patients received up to eight three-week cycles of CVP chemotherapy. Patients in the R-CVP arm received Rituxan 375 mg/m2 on Day 1 of each treatment cycle.
-- R-CVP improved median progression-free survival to 2.4 years from 1.4 years for CVP chemotherapy alone.
-- R-CVP reduced the risk of disease progression, relapse or death by 56 percent compared to CVP chemotherapy alone (hazard ratio = 0.44 p
FDA aprobã douã noi Indicaþii pentru Rituxan (R), la pacienþii cu non-Hodgkin's Lymphoma - FDA Approves Two New Indications For Rituxan(R) In Patients With Non-Hodgkin's Lymphoma - articole medicale engleza - startsanatate