Genentech, Biogen Idec and Roche are seeking a new OK for their top-selling drug Rituxan (rituximab) for the first-line treatment of patients with intermediate or aggressive B cell non-Hodgkin’s lymphoma plus conventional chemotherapy. The companies have requested a priority review from the US Food and Drug Administration for the filing, which would see a decision on approvability within the next six months.
Rituxan is currently approved for use in relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma. It also pulls in significant sums for its owners. For example, during the second quarter, Genentech recorded Rituxan sales of $450 million dollars [[120705a]], while Roche saw sales of $1.5 billion during the first six months [[20/07/05a]].
The dossier filing is based on data from three randomized studies of Rituxan combination therapy in 1,854 previously-untreated NHL patients. "The addition of Rituxan to CHOP represents the first significant improvement in intermediate grade or aggressive CD-20-positive, B-cell NHL treatment since the development of the CHOP regimen more than 30 years ago," said Burt Adelman, Biogen Idec's executive vice president, development.