FDA Expands Blinatumomab Approval in Early-Stage ...
Blinatumomab (Blincyto) approved by FDA for CD19-positive B-ALL treatment, supported by phase 3 E1910 study showing improved overall survival with chemotherapy. Study involved 488 patients, focusing on OS, relapse-free survival, and MRD status, with no new safety concerns identified.
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Blinatumomab (Blincyto) approved by FDA for CD19-positive B-ALL treatment, supported by phase 3 E1910 study showing improved overall survival with chemotherapy. Study involved 488 patients, focusing on OS, relapse-free survival, and MRD status, with no new safety concerns identified.
Adding blinatumomab to consolidation chemotherapy significantly improved overall survival (85% vs 68%) and relapse-free survival (80% vs 64%) in MRD-negative B-cell precursor ALL patients, establishing a new standard of care. FDA approved blinatumomab for CD19-positive, Ph-negative B-cell precursor ALL in consolidation phase, supported by E1910 trial findings.
FDA approved blinatumomab for Ph-negative BCP ALL patients, based on Studies E1910 and 20120215 showing improved survival rates. Common adverse reactions included neutropenia, thrombocytopenia, and anaemia. The review utilized Project Orbis and Real-Time Oncology Review, with priority and breakthrough designations.