The European Commission has granted approval to Roche's MabThera (rituximab), a new treatment that has been shown to significantly prolong remission in patients with chronic lymphocytic leukaemia (CLL), a common form of incurable cancer.
MabThera will now be available as a combination treatment with chemotherapy for patients who have experienced a recurrence of the cancer after treatment or who have not responded appropriately to therapy.
Approval was based on the company's Reach trial, which showed that patients with relapsed or refractory CLL who were treated with MabThera in combination with chemotherapy lived an average ten months longer without their disease progressing, compared to those who received chemotherapy alone.
Reach trial principal investigator Professor Tadeusz Robak said that this approval will make MabThera plus chemotherapy the gold-standard therapy for people living with relapsed or refractory CLL.
"Although all patients with CLL will unfortunately eventually relapse, treatment with MabThera significantly prolongs remission. This will help ease the burden of the cancer and enable patients to enjoy the relative freedom that comes with this relief from symptoms," Robak said.
Earlier in 2009, Roche received marketing approval for MabThera in combination with chemotherapy in previously untreated patients with advanced CLL.