FDA Approves Amgen’s BLINCYTO for ALL

The US Food and Drug Administration (FDA) has granted approval for Amgen’s BLINCYTO (blinatumomab) for patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) during the consolidation phase. This approval covers both adult and pediatric patients aged over one month, regardless of their measurable residual disease (MRD) status.

The decision to approve this new indication for BLINCYTO is rooted in the results from the Phase III E1910 clinical trial. Conducted by the ECOG-ACRIN Cancer Research Group, the study assessed the efficacy of BLINCYTO in the postinduction consolidation treatment phase for newly diagnosed patients. The primary goal was to enhance remission depth and achieve long-term responses.

Data from the trial demonstrated that adding BLINCYTO to consolidation chemotherapy significantly improved overall survival (OS) rates compared to chemotherapy alone. Specifically, the three-year OS rate was 84.8% for patients receiving the combination of BLINCYTO and chemotherapy, compared to 69% for those who received chemotherapy only. After a median follow-up of four and a half years, the five-year OS rate was 82.4% in the BLINCYTO and chemotherapy group, versus 62.5% in the chemotherapy-only group.

Jay Bradner, executive vice-president and chief scientific officer of Amgen’s research and development, highlighted the impact of BLINCYTO on B-ALL, describing it as an aggressive blood cancer with a persistent high unmet need. Bradner emphasized that BLINCYTO had already benefited thousands of B-ALL patients over the past decade. The new approval in the frontline consolidation phase, regardless of MRD status, will help the therapy reach even more patients. BLINCYTO is recognized as a first-in-class bispecific T-cell engager (BiTE) therapy.

BLINCYTO works as an immuno-oncology therapy by targeting CD19 surface antigens on B cells. It has previously received breakthrough therapy and priority review designations from the FDA due to its innovative approach. In the US, BLINCYTO is approved for several indications, including CD19-positive B-ALL in first or second complete remission with MRD equal to or greater than 0.1%, and relapsed or refractory CD19-positive B-ALL in both adults and children aged over one month.

Additionally, in May 2024, Amgen’s Bkemv (eculizumab-aeeb) received FDA approval as the first interchangeable biosimilar to Soliris (eculizumab) for treating certain rare diseases.

The expanded approval of BLINCYTO marks a significant advancement in the treatment of B-ALL, offering new hope and improved survival rates for patients diagnosed with this aggressive form of blood cancer. As a BiTE therapy, BLINCYTO continues to make strides in oncology, reinforcing Amgen’s commitment to addressing high unmet medical needs in cancer treatment.