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.
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.
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.