FDAnews Drug Daily Bulletin

PRIORITY REVIEW GRANTED TO RITUXAN SBLA FOR NON-HODGKIN'S LYMPHOMA

Nov. 3, 2005
A A

The FDA has granted priority review to Genentech and Biogen Idec's supplemental biologics license application (sBLA) for Rituxan as a front-line treatment for non-Hodgkin's lymphoma.

Based on the priority review designation, the FDA must complete its review of the application within six months of the submission date. The companies filed the sBLA on Aug. 12.

Genentech and Biogen are seeking approval of Rituxan (rituximab) for use in previously-untreated patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.

The blockbuster drug, which generated worldwide sales of $1.7 billion in 2004, is currently approved to treat relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma.

More than 56,000 non-Hodgkin's lymphoma cases are diagnosed annually in the U.S. Roughly 50 percent of patients suffer from the intermediate-grade or aggressive form of the disease, while the remaining 50 percent have follicular non-Hodgkin's lymphoma. Rituxan has already been prescribed to more than 730,000 patients worldwide, the companies said.