Genentech, Inc., Biogen Idec, Inc. and Roche have completed the filing of a supplemental Biologics License Application (sBLA) with the US FDA for an additional indication for Rituxan (Rituximab), in previously untreated (front-line) patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin's lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.
As part of the Rituxan sBLA filing, the companies have requested Priority Review designation from the FDA. Rituxan is currently approved for use in relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma.
The sBLA filing is based on efficacy and safety data from three randomized, controlled, multi-centre studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin's lymphoma. All three trials evaluated the efficacy endpoint of overall survival, said a release here.
"These three Phase III studies add to the body of data regarding Rituxan in the treatment of non-Hodgkin's lymphoma," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "We are pleased to be filing these data with the FDA, and we are committed to working closely with the agency during the review process."
The LNH 98-5 trial conducted by GELA 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 Diffuse Large B-Cell Lymphoma (DLBCL). Based on the results of this trial, in March 2002, Rituxan, which is known as MabThera in Europe received approval from the European Union health authority to treat aggressive NHL.
The M39045 (MInT) trial was designed to evaluate the efficacy and safety of Rituxan in combination with CHOP or other anthracycline-based induction chemotherapy regimens in 823 patients between the ages of 18-60.
There are currently more than 360,000 people in the United States living with NHL. Approximately 50 percent have aggressive NHL, while the other half are patients with indolent or follicular lymphoma. According to the American Cancer Society, more than 56,000 men and women in the United States are diagnosed with NHL each year.