Blincyto is intended to treat pediatric and adult patients with a specific type of acute lymphoblastic leukemia.
Amgen earned accelerated approval for the drug in 2014. The FDA’s Accelerated Approval Program allows for the earlier approval of drugs that fill an unmet clinical need, according to the agency’s website.
The full approval of Blincyto was contingent on the positive results of a clinical trial to confirm the drug’s efficacy. Trial participants taking Blincyto had a median overall survival length of 7.7 months compared to 4 months for those using a standard chemotherapy regimen.
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