FDA has approved Amgen’s BLINCYTO® (blinatumomab) for treating adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, irrespective of measurable residual disease (MRD) status.
The approval was based on the results of the phase 3 E1910 clinical trial for Blincyto®, offering hope to patients with CD19+ B-ALL.
Jay Bradner, M.D., EVP, R&D, and Chief Scientific Officer at Amgen, acknowledged the significant milestone of the FDA’s recent approval.
He emphasized that BLINCYTO, which has helped thousands of CD19+ B-ALL patients, can reach even more patients in the frontline consolidation phase.
Selina M. Luger, M.D., from the University of Pennsylvania’s Perelman School of Medicine and Abramson Cancer Center, highlighted Blincyto® significant impact in the E1910 study.
Blincyto® reduced death risk and improved survival, setting a new standard for CD19+ B-ALL care beyond chemotherapy alone.
E. Anders Kolb, M.D., CEO of The Leukemia & Lymphoma Society, recognized the FDA approval of a new CD19+ B-ALL treatment as a significant milestone.
He emphasized the importance of Blincyto® in addressing high recurrence risks and providing early effective options for patients.
The E1910 study was sponsored by ECOG-ACRIN with public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).
Source: FDA APPROVES BLINCYTO® (BLINATUMOMAB) IN CD19-POSITIVE PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) IN THE CONSOLIDATION PHASE
https://www.amgen.com/newsroom/press-releases/2024/06/fda-approves-blincyto-blinatumomab-in-cd19positive-philadelphia-chromosomenegative-bcell-precursor-acute-lymphoblastic-leukemia-ball-in-the-consolidation-phase
