A Phase III study conducted by Genentech, a member of the Roche group, showed that patients with follicular lymphoma who received Rixutan alongside chemotherapy lived significantly longer without the disease worsening.
Genentech, Roche and Biogen Idec will now discuss steps for a potential new indication for Rituxan with the US Food and Drug Administration (FDA) and European regulatory authorities.
Genentech executive vice president, global development and chief medical officer Hal Barron said that the primary treatment goal in follicular lymphoma is to extend the time patients live with their disease under control.
“This study showed that the extended use of Rituxan helped patients live even longer without their disease advancing and we look forward to discussing these new data with the FDA,” Barron said.
Rituxan was initially discovered by Biogen Idec and received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
The treatment was also approved in the EU under the trade name MabThera.