Roche wins EU approval for leukemia drug

The approval is based on compelling results from the pivotal Phase III study CLL8, the company said.

According to Roche, the results showed that patients receiving MabThera in combination with chemotherapy as first-line treatment lived an average of 40 months without their cancer progressing compared to an average of 32 months for patients receiving chemotherapy alone.

At present, chronic lymphocytic leukemia (CLL) is considered incurable and the aim of treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening. The results of CLL8 demonstrate that patients treated with MabThera lived longer without their disease progressing, reducing the number of frequent hospital visits, the company maintained.

The CLL8 study is an international study conducted by the German CLL Study Group and Michael Hallek (University Hospital Cologne, Germany) in collaboration with Roche. It included 817 patients with CLL receiving first-line treatment. The study was conducted at 191 study sites across 11 countries. In this randomized study, patients received either MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The primary endpoint of the study was progression-free survival.

William Burns, CEO of Roche’s pharmaceuticals division, said: “Today’s approval of MabThera in CLL is great news for patients suffering from this devastating disease. We have seen MabThera transformed the lives of more than 1.5 million patients with non-Hodgkin’s lymphoma and we hope this approval will bring about a similar change for people suffering from this condition.”