January 29, 2023
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Amgen applies for FDA approval of Blincyto


Thousand Oaks-based Amgen submitted an application for Blincyto to the U.S. Food and Drug Administration, the company announced on Feb. 14.

Amgen aims to gain approval for Blincyto to treat Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The drug was previously granted breakthrough therapy designation and accelerated approval in December 2014.

“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,” said Dr. Sean Harper, executive vice president of research and development at Amgen.

• Contact Alex Kacik at akacik@pacbiztimes.com.