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news.Genentech has received approval from the US Food and Drug Administration (FDA) for Rituxan (rituximab), as a maintenance treatment for patients with advanced follicular lymphoma who have responded to initial treatment with Rituxan plus chemotherapy.
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The approval follows the approval of Rituxan for this indication by the European Commission in October 2010.
The FDA approval was based on a Phase III study, which showed that Rituxan administration in patients who responded to initial treatment with Rituxan plus chemotherapy nearly doubled the progression free survival, compared to those who stopped the treatment.
Roche Global Product Development, chief medical officer, Hal Barron said the maintenance use of Rituxan offers people with this incurable disease the opportunity to live longer without their disease getting worse, a primary goal of treatment