(Reuters) – The U.S. Food and Drug Administration said on Thursday it approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.
The treatment, marketed as Lumoxiti, was approved for treating a stubborn form of the disease or a relapse in patients who have received at least two prior therapies, the FDA here said.
Lumoxiti includes a boxed warning advising health care professionals and patients about the risk of developing capillary leak syndrome, a condition in which fluid and proteins leak out of tiny blood vessels.
The warning also notes the risk of hemolytic uremic syndrome, a condition caused by the abnormal destruction of red blood cells.
Hairy cell leukemia is a rare form of blood cancer in which the bone marrow makes too many B cells, a type of white blood cell that fights infection.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Anil D’Silva