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