Amgen's Blincyto gains new approval for adult ALL consolidation in UK
Amgen's immunotherapy drug Blincyto (blinatumomab) has received a new indication from the UK's MHRA for adult patients with Philadelphia chromosome-negative B-cell precursor ALL in the consolidation phase.
Amgen has secured a new indication for its immunotherapy drug Blincyto (blinatumomab) from the UK's Medicines & Healthcare products Regulatory Agency (MHRA). The expanded approval allows Blincyto to be used in adult patients with Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL) during the consolidation phase of treatment.
Consolidation therapy follows initial induction treatment for ALL and aims to eliminate any remaining leukaemia cells to prevent relapse. This new license addresses an unmet need for targeted treatments that can reduce this risk. Blincyto will now be available as an addition to standard chemotherapy regimens for eligible adult patients.
The expanded indication is supported by findings from the Phase 3 E1910 clinical trial, conducted by the ECOG-ACRIN Cancer Research Group. The study compared adding blinatumomab to standard consolidation chemotherapy versus chemotherapy alone in newly diagnosed, Philadelphia chromosome-negative B-ALL adult patients achieving minimal residual disease (MRD) negativity.
Results showed a significant improvement in overall survival. At a median follow-up of 4.5 years, the 5-year overall survival rate was 82.4% in the blinatumomab plus chemotherapy arm, compared to 62.5% in the chemotherapy-only arm. This represented a 56% reduction in the risk of death.
This approval provides a new treatment option aimed at improving survival and reducing relapse rates for adults with B-ALL in the UK.