WASHINGTON (AP) - The Food and Drug Administration has approved a new drug from Pharmacyclics and Janssen Biotech Inc. to treat a rare and aggressive form of blood cancer.
The agency says it approved Imbruvica for patients with mantle cell lymphoma who have already received at least one previous drug therapy. The cancer typically starts in lymph nodes but has usually spread to the bone marrow and other organs by the time it is diagnosed.
The once-a-day capsule works by blocking a protein that allows the cancer to multiply and spread.
Imbruvica is the second medicine approved under FDA's breakthrough designation, which was authorized by Congress last year. The classification is designed to speed up development of promising drugs by providing companies with extra meetings and earlier communication with FDA scientists.