Roche Gets EC Nod for Follicular Lymphoma Maintenance Therapy
CD20 antibody MabThera doubled PFS after chemotherapy in Phase III trial.
Roche’s antibody therapeutic MabThera (rituximab) has been rubber-stamped by the European Commission as first-line maintenance treatment of follicular lymphoma. Approval is based on data from the Phase III Prima study, which found that MabThera maintenance therapy doubled progression-free survival compared with no maintenance therapy. The Prima study has also been used as the basis of a rituximab sBLA filing to FDA for the same follicular lymphoma indication, which Genentech submitted in March. The antibody is trademarked Rituxan in the U.S., Japan, and Canada.
“The approval of MabThera maintenance therapy in the EU is a significant step that will change the way we manage this chronic disease,” claims Gille Salles, M.D., principal investigator for the Prima trial at the Centre Hospitalier Lyon Sud.
The Prima study compared the effects of MabTherapy maintenance therapy with observation alone, in patients who had already responded to initial treatment with MabTherapy plus chemotherapy. The results showed that after two years, 82% of MabThera-treated patients were still in remission, compared with 66% of patients who didn’t receive maintenance therapy.
In Europe MabThera is already marketed for the treatment of a range of hematological cancer indications. These include the treatment of previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with chemotherapy; the treatment of previously untreated patients with Stage III-IV follicular lymphoma in combination with chemotherapy; the maintenance therapy of relapsed/refractory follicular lymphoma that has previously responded to induction therapy with chemotherapy with or without MabThera; the treatment of CD20-positive diffuse large B-cell non-Hodgkin lymphoma in combination with CHOP chemotherapy; and as monotherapy for patients with stage III-IV follicular lymphoma who are chemoresistant or experience their second or subsequent relapse after chemotherapy.
MabThera/Rituxan is also approved in markets worldwide in combination with methotrexate for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis. Roche reported that overall global sales of MabThera/Rituxan for oncology and autoimmune disease indications were SwFr 3.3 billion (about $3.4 billion) in the first half of 2010, up 9% on the same period in 2009. The drug was Roche’s second best-selling pharmaceutical during period, behind Avastin, which had sales of SwFr 3.4 billion (just shy of $3.5 billion).