Roche has announced 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.
2/4 “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).