FDA starts review of Roche leukemia drug - Drug Discovery and Development

Swiss drugmaker Roche said Wednesday the Food and Drug Administration will make a decision on its leukemia drug obinutuzumab by Dec.20.

Roche’s Genentech unit is developing obinutuzumab as a treatment for chronic lymphocytic leukemia. Genentech said the FDA will conduct a priority review, meaning it will make a decision in six months instead of the usual 10 months.

The company says obinutuzumab is an antibody designed to kill cancer cells and encourage a patient’s immune system to fight them. In a late-stage trial a combination of obinutuzumab and chemotherapy was superior to chemotherapy at slowing the progress of the disease, as patients treated with obinutuzumab had median survival of 23 months before death, relapse or new disease progression. That compares with 10.9 months for the chemotherapy patients.

The FDA has also deemed obinutuzumab a breakthrough therapy. That designation speeds up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases.