Latest U.S. approval follows similar EU sanction in October 2010.
FDA has approved Roche’s Rituxan (rituximab; MabThera in the EU) as maintenance therapy for patients with advanced follicular lymphoma who responded to initial treatment using Rituxan plus chemotherapy. The drug was cleared for this indication in Europe in October 2010.
The latest approval in the U.S. was based on data from the Phase III PRIMA trial, which showed that for patients who responded to induction therapy using chemotherapy plus Rituxan, continuing with Rituxan as single maintenance therapy for another two years nearly doubled progression-free survival time. PRIMA included 1,217 patients with previously untreated advanced follicular lymphoma.
First developed by Biogen Idec Rituxan/MabThera is an anti-CD20 antibody that gained its initial U.S. approval in November 1997, for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin lymphoma (NHL. Initial clearance of the drug as MabThera in the EU was first received in June 1998. The drug is now approved for various uses in the treatment of NHL and chronic lymphocytic leukemia. Approvals are also in place in the U.S. and Europe for use of Rituxan/MabThera combined with methotrexate as a treatment for rheumatoid arthritis (RA) in patients who have had an inadequate response to anti-TNF therapy.
Genentech and Biogen Idec are responsible for commercializing Rituxan in the U.S., and Roche markets MabThera in the rest of the world, except Japan, where it is co-marketed by Chugai and Zenyaku Kogyo. In its report for the first half year of 2010, Roche notes combined sales of of Rituxan/MabThera for NHL, CLL, and RA rose 9% to CHF 3.3 billion (about $3.4 billion) and accounted for 17% of its overall sales for the period. The drug is Roche’s second biggest selling pharmaceutical, behind the anticancer drug Avastin.