Amgen applies to broaden use of Blincyto

Biotech company Amgen submitted an application to the U.S. Food and Drug Administration for Blincyto, a drug used in the treatment of lymphoblastic leukemia, to broaden its uses and treatments.
“Acute lymphoblastic leukemia is one of the most aggressive B-cell malignancies, and adult patients who relapse or are refractory to treatment often go through multiple lines of therapy,” Sean Harper, Amgen's executive vice president of research and development, said. “We are excited to potentially receive full approval for Blincyto, the first immunotherapy to demonstrate an overall survival benefit versus standard of care chemotherapy in patients with relapsed B-cell precursor.”
Blincyto was granted a priority review designation by the FDA, and was approved in the United States. In November 2015 it was granted conditional marketing rights in Europe for adult treatment.