Rituxan/MabThera is a therapeutic antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells.
The study results revealed that immediate use of single agent Rituxan/MabThera followed by continued use of Rituxan/MabThera delayed the need for chemotherapy and decreased the risk of disease worsening (progression-free survival), compared to watchful waiting.
Roche said the international, multicentre, randomised, Phase III study enrolled 462 patients with previously untreated asymptomatic Stage II-IV follicular lymphoma.
The study was designed to compare the safety and efficacy of first-line induction followed by maintenance use of Rituxan/MabThera alone, compared to careful observation.
Immediate use of Rituxan/MabThera followed by maintenance, decreased the risk of needing additional therapy by 80% and decreased the risk of disease worsening by 79%, when compared to watchful waiting.
The median time to initiation of new therapy (chemotherapy or radiotherapy) for patients managed by watchful waiting was 34 months and the median progression free survival was 23 months.
However, in patients receiving Rituxan/MabThera followed by maintenance, the median of these parameters was significantly longer and has not been reached for four years.
Follicular lymphoma (FL) is a cancer of the blood and is characterised by period of relapse and remission, and it affects about 286, 000 people worldwide every year.
Rituxan/MabThera, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
It was approved in the EU under the trade name MabThera in June 1998.