MabThera approved in Europe for first line maintenance treatment of follicular lymphoma, a common type of blood cancer, Roche
Release Date: 2010-10-29
Prolonged treatment with MabThera allows patients with follicular lymphoma to be protected for longer from their disease getting worseRoche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the use of MabThera (rituximab) as a maintenance treatment for people suffering from follicular lymphoma who have responded to initial induction therapy. The approval of MabThera maintenance expands effective treatment options for people with this common type of incurable blood cancer, doubling the likelihood of them living longer without their disease worseningi. Maintenance treatment is an important approach to blood cancer management as it reduces the risk of relapse and the use of repeated chemotherapy, ultimately improving the lives of follicular lymphoma patients.
“The approval of MabThera maintenance therapy in the EU is a significant step that will change the way we manage this chronic disease,” said Professor Gilles Salles, Centre Hospitalier Lyon Sud, France, and principal investigator for the PRIMA trial. “Having access to this new treatment option will enable patients with this serious form of blood cancer to live their lives with their disease under better control.”
The approval is based on the results from the phase III PRIMA study which demonstrated that continuing MabThera for two years (maintenance treatment) in patients who responded to initial treatment with MabThera plus chemotherapy doubled the likelihood of these patients living without their disease worsening (known as progression-free survival) compared to those who did not receive maintenance therapy (based on a hazard ratio of 0.50, 95% CI, 0.39; 0.64; p=<0.0001). After two years of follow-up, 82% of patients who received MabThera maintenance were in remission compared to 66% of patients who did not. The benefit of maintenance treatment was seen across all major patient groups analysed within the trial, regardless of their tumour burden, age, gender or their response to initial treatment.
“The European approval of first line MabThera maintenance treatment of follicular lymphoma is excellent news for patients,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer at Roche. “Reducing the number of times the disease relapses and requires subsequent treatments will improve the lives of patients with this specific type of blood cancer.”
Based on the PRIMA study data, Genentech also submitted a sBLA (supplemental Biologics License Application) for MabThera (known as Rituxan in the United States, Japan and Canada) in March 2010 to the U.S. Food and Drug Administration (FDA).
Follicular lymphoma (FL), a cancer of the blood, is a common type of non-Hodgkin’s lymphoma (NHL). Approximately 286’000 people worldwide are diagnosed with NHL each yearii, and FL accounts for about one in four of these cases. Follicular lymphoma unfortunately remains incurable and despite substantial progress, patients ultimately relapse and relapses require additional treatments and can lead to fatal outcomes.
Follicular lymphoma can occur at any time during adulthood, though people are typically diagnosed during their fifties and sixties, affecting both men and women.
| Type: | NORMAL |
| Company: | Roche |
| Country: | Switzerland |