The company is to make the filing after a pivotal trial showed two years of maintenance therapy with the drug, known as Rituxan in the US, dramatically improved survival for patients with the condition.
In the trial the risk of death was halved for patients who received MabThera maintenance therapy, compared to those who received no maintenance treatment, irrespective of their initial therapy.
“We have not seen such an impressive improvement in progression free and overall survival for indolent NHL (non-Hodgkin’s lymphoma) in the last 30 years,” said Professor Marinus van Oers from the academic medical center of the University of Amsterdam and lead investigator of the study. “Maintenance therapy with MabThera may well become the new standard of care for these patients.”