January 29, 2023
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FDA approves Amgen’s Blincyto


The U.S. Food and Drug Administration approved Amgen’s drug Blincyto for treating pediatric leukemia patients Sept. 1.

In Dec. 2014, the FDA approved Blincyto to treat patients with precursor B-cell acute lymphoblastic leukemia, which is a rare form of the disease. On Sept. 1, the agency extended Blincyto’s approval to include pediatric patients with another form of the same disease.

The FDA approved the drug under its accelerated approval program, which treats serious diseases and fills unmet medical needs.

An Amgen study tracking the effects of the drug on 93 pediatric patients influenced the approval, Amgen said. The study is ongoing.

Blincyto does come with a cost though, amounting to around $178,000 per year for treatments.

-Contact Philip Joens at pjoens@pacbiztimes.com