FDA approves Roche drug for chronic leukemia based on research that it slows disease

WASHINGTON -- The Food and Drug Administration on Friday 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 haven't previously been treated for the disease.

Gazyva works by killing cancer cells and encouraging the immune system to fight against them.

Chronic lymphocytic leukemia develops slowly over time and is usually diagnosed in the elderly. More than 15,600 Americans will be diagnosed and 4,580 of them will die from the disease this year, according to estimates from the National Cancer Institute.

The FDA approved the drug based on a study showing Gazyva plus chemotherapy was superior to chemotherapy alone at 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.

The injectable biotech drug is the first medicine approved under FDA's breakthrough designation, which was authorized by Congress last year. The new designation is designed to speed up the approval of promising drugs by providing companies with extra meetings and earlier communication with FDA scientists to discuss drug development.

Gazyva will be marketed by Roche's Genentech unit, which is based in South San Francisco.

A spokeswoman for Genentech said the drug would cost $41,300 for one course of treatment, which lasts six months.

Common side effects seen in company studies included anemia, fever, muscle and bone pain and lower levels of white blood cells.