Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older 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.
This marks Blincyto’s third approval in the U.S. market and was primarily based on the results of the Phase III E1910 clinical trial. The consolidation treatment for B-ALL patients is designed to deepen remission and enhance the durability of treatment responses. In the trial, the addition of Blincyto to multiphase consolidation chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, with a 3-year OS rate of 84.8% for Blincyto versus 69% for chemotherapy alone, and a hazard ratio for OS of 0.42. At a median follow-up of 4.5 years, the 5-year OS was 82.4% for the Blincyto regimen versus 62.5% for chemotherapy alone.
B-ALL is an aggressive form of blood cancer with a relatively high risk of recurrence post-initial treatment. In addition to the latest approval for the consolidation phase, Blincyto is also approved to treat CD19-positive B-ALL in first or second complete remission with MRD of 0.1% or greater in adults and pediatric patients aged one month or older, and in relapsed or refractory CD19-positive B-ALL in the same patient demographic. The latter indication was Blincyto’s first market approval, granted in December 2014.- Flcube.com
