EU approves Blincyto (blinatumomab) for Ph- relapsed or refractory B-precursor acute lymphoblastic leukemia- Amgen
The European Commission has granted conditional marketing authorization for Blincyto (blinatumomab), from Amgen, for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). The conditional marketing authorization for Blincyto is based on results of two Phase II studies, study ‘211 and ‘206. In the pivotal ‘211 trial, 42.9 percent of patients achieved complete remission (CR) or CR with partial hematological recovery (CRh*) with single-agent Blincyto.
The most serious adverse reactions that occurred during Blincyto treatment in the pivotal ‘211 trial included infections, neurologic events, neutropenia/febrile neutropenia, cytokine release syndrome and tumor lysis syndrome.
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