This article is more than 5 years old. Information may no longer be current.
FDA approves Blincyto for pediatric relapsed, refractory B-cell precursor ALL
Click Here to Manage Email Alerts
The FDA approved a new indication for blinatumomab to treat pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to the drug’s manufacturer.
The phase 1/2 '205 trial evaluated the safety and efficacy of blinatumomab (Blincyto, Amgen) in 93 pediatric patients with relapsed or refractory B-cell precursor ALL.
Patients have completed treatment in this study and are being monitored for long-term efficacy.
The most common adverse events included pyrexia, headache, nausea, edema, hypokalemia, anemia, febrile neutropenia, neutropenia, thrombocytopenia and abdominal pain.
This indication is approved under accelerated approval; continued approval may be contingent upon verification of clinical benefit in subsequent trials, the release said.