March 29 (Reuters) - The U.S. Food and Drug Administration on Thursday expanded the use of Amgen Inc’s leukemia drug Blincyto to include patients who are in remission but still have residual signs of the disease.
The drug, part of a class known as bispecific antibodies, is already approved for patients with acute lymphoblastic leukemia (ALL) whose cancer has returned after treatment or did not respond to previous treatment, such as a stem cell transplant or chemotherapy.
The expanded approval is for patients with “minimal residual disease,” meaning the presence of cancer cells below a level that can be seen under a microscope. Such patients still have an increased risk of relapse.
An estimated 5,960 Americans will be diagnosed with ALL this year, and around 1,470 will die from the disease, according to the National Cancer Institute.
Amgen’s sales of Blincyto totaled $175 million last year. (Reporting By Deena Beasley; Editing by Bernadette Baum)