FDA approves Roche leukemia drug Gazyva

• Gazyva Demonstrated an 84 Percent Reduction in the Risk of Disease Worsening or Death When Combined with Chemotherapy Compared to Chemotherapy Alone
• Gazyva is the First Medicine Approved with the FDA's Breakthrough Therapy Designation

The Food and Drug Administration approved a new drug from Roche to help treat patients with a type of cancer of the blood and bone marrow. The agency cleared Gazyva to fight chronic lymphocytic leukemia in combination with chemotherapy in patients who have not previously been treated for the disease.

Gazyva works by killing cancer cells and encouraging the immune system to fight against them. The agency approved the drug based on a study showing Gazyva plus chemotherapy was superior to chemotherapy alone in slowing the progress of the disease. Patients treated with Gazyva had median survival of 23 months before death, relapse or worsening of their disease. That compares with 11.1 months for the chemotherapy patients. Gazyva will be marketed by Roche’s Genentech unit.