Datamonitor: Roche / Genentech / Biogen Idec - US approval will boost Rituxan dominance

The FDA has approved Rituxan for first-line maintenance treatment of patients with advanced follicular lymphoma that responded to initial treatment with Rituxan plus chemotherapy. Sales are expected to increase across the seven major markets following the FDA’s decision and, as a result, Rituxan looks set to dominate in this indication.

The FDA has approved Rituxan/MabThera (rituximab; Biogen Idec/Genentech/Roche/Chugai/Zenyaku Kogyo) for first-line maintenance treatment for advanced follicular lymphoma (FL) based on the Phase III PRIMA study. Sponsored by Groupe d'Etude des Lymphomes de L'Adulte, this was an international, multicenter, randomized trial that enrolled 1,217 patients with previously untreated FL. The trial investigated Rituxan maintenance following initial therapy of either eight cycles of R-CVP (Rituxan, cyclophosphamide, vincristine, and prednisone) or six cycles of R-CHOP (Rituxan, cyclophosphamide, doxorubicin, vincristine, and prednisone), or R-FCM (Rituxan, fludarabine, cyclophosphamide, and mitoxantrone). After a two-year follow up, 82% of patients that received Rituxan maintenance were in remission compared to 66% in the observation arm, demonstrating an improvement in progression-free survival.

Rituxan is a monoclonal antibody that selectively targets the CD20 marker present on the surface of malignant (and normal) B cells. Originally developed by Biogen Idec, it is approved for CD20-positive FL as a single agent and in combination with chemotherapy. Rituxan is also approved for the treatment of diffuse large B-cell lymphoma and for certain patients with rheumatoid arthritis and chronic lymphocytic leukemia.

FL is the most commonly diagnosed indolent form of non-Hodgkin's lymphoma in the seven major markets (the US, Japan, France, Germany, Italy, Spain, and the UK). Datamonitor estimates that over 31,000 patients were diagnosed with FL in these markets in 2010, and has conducted physician research showing that approximately 50% of US FL patients and 40% of EU FL patients are currently treated with Rituxan maintenance therapy outside clinical trials.

Rituxan is an established first-line therapy in FL and recent Phase III results have demonstrated that immediate treatment with Rituxan provides an impressive reduction in FL progression rates. As such, following this recent FDA approval, Rituxan looks set to increase its dominance in this indication, as it is likely that it will be approved in three FL treatment interventions: immediate monotherapy, induction therapy in combination with chemotherapy, and maintenance monotherapy.

The National Comprehensive Cancer Network in the US already recommends Rituxan maintenance therapy. It was approved for this indication in the EU in October 2010. The recent FDA approval will boost the number of patients receiving Rituxan as clinician confidence increases and maintenance treatment becomes routine. Sales in the US are likely to rise, as US insurance companies will now cover the costs of the lengthy regimens. In combination with the recent EU approval, this will significantly increase the sales of Rituxan in the seven major markets.

Related research

Datamonitor: Stakeholder Insight: Non-Hodgkin's Lymphomas Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL):
http://www.reports-research.com/market-surveys/stakeholder-insight-hodgkins-lymphomas-diffuse-large-cell-lymphoma-dlbcl-follicular-lymphoma-p-66420.html

Datamonitor: Pipeline Insight: Lymphomas, Multiple Myeloma & Myelodysplastic Syndromes - Optimization of clinical practice creates opportunities for emerging therapies:
http://www.reports-research.com/market-surveys/pipeline-insight-lymphomas-multiple-myeloma-myelodysplastic-syndromes-optimization-clinical-practice-creates-opportunities-emerging-therapies-p-74947.html

Datamonitor: Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response:
http://www.reports-research.com/market-surveys/drug-approval-trends-emea-process-improvements-heightened-scrutiny-industry-response-p-24158.html

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