THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced the European Commission has granted conditional marketing authorization for BLINCYTO (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia. BLINCYTO was granted orphan drug designation by the European Medicines Agency in 2009 for the treatment of acute lymphoblastic leukemia.
The company said the conditional marketing authorization for BLINCYTO is based on results of two Phase 2 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 with single-agent BLINCYTO.
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