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.
Amgen applies to broaden use of Blincyto
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