MabThera shows improved leukaemia survival benefits
pharmafile | December 14, 2009 | News story | Sales and Marketing |Â Â CLL, MabThera, RocheÂ
MabThera/Rituxan is the first treatment to show improved survival in previously untreated patients with chronic lymphocytic leukaemia (CLL), according to Roche.
Updated study results were presented at the 51st Meeting of the American Society of Hematology in New Orleans.
The disease is incurable, but phase III study CLL8 showed patients lived longer when treated with MabThera (rituximab) compared to chemotherapy alone.
University of Cologne Professor Michael Hallek led the randomised trial, which included 817 patients in 11 countries. He said it showed “for the first time that a specific first-line treatment for CLL could improve overall survival”.
“The results support the recommendation to use fludarabine, cyclophosphamide and rituximab (FCR) as standard therapy in physically fit patients with CLL,” Hallek added.
The new data showed 87.2% of patients receiving MabThera/Rituxan plus FC were alive after more than three years.
This compared to 82.5% of patients who received FC alone.
The median survival has not yet been reached, Roche says, but no new safety issues were observed in CLL8.
After more than three years of follow-up, patients on MabThera plus FC had a median progression-free survival of 51.8 months compared to 32.8 months for those who just received FC.
CLL8 data first presented last year showed that the drug in combination with chemotherapy offered patients an average of 40 months without the cancer progressing, compared to 32 months for those on chemotherapy alone.
MabThera therefore offers patients “the very real hope of living longer”, said Roche chief executive William Burns.
The blockbuster, already used to treat non-Hodgkin’s Lymphoma and rheumatoid arthritis, was approved in September for a new licence in Europe for use in previously treated CLL patients.
Treatment with MabThera had already been found to significantly prolong remission, allowing patients some relief from symptoms.
CLL is the most common type of leukemia in adults, accounting for approximately 30-40% of all forms of leukemia in Western countries.
Overall incidence of CLL is around three per 100,000 and is 30% more common in men than women
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