The EU approved Roche's MabThera in combination with chemotherapy for use in patients with previously untreated chronic lymphocytic leukemia (CLL).
The approval stems from the Phase III CLL8 results that showed patients receiving MabThera as first-line treatment while on chemotherapy lived an average of 40 months without their cancer progressing, says the company. This is compared to an average of 32 months for patients only receiving chemotherapy as treatment.
The CLL8 trial consisted of 817 patients with CLL receiving first-line treatment and was conducted at 191 study sites across 11 countries.
MabThera is known as Rituxan in the U.S., Japan, and Canada, and indicated for the treatment of severe active rheumatoid arthritis in adult patients as well as certain B-cell non-Hodgkin's lymphomas. Last year, Rituxan's full year revenue in the U.S. was $1.1 billion.
In January of this year, Roche submitted an MAA to the European Medicines Agency (EMEA) for the use of MabThera in patients who have previously been treated for their CLL but whose cancer has returned.