The US Food and Drug Administration (FDA) has approved Amgen’s BLINCYTO (blinatumomab) for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) patients in the consolidation phase.

This new indication for BLINCYTO is for adults and paediatric patients aged over one month with B-ALL, irrespective of the measurable residual disease status.

The approval is based on the Phase III E1910 clinical trial, led by ECOG-ACRIN Cancer Research Group, which evaluated BLINCYTO in the postinduction consolidation treatment phase of newly diagnosed patients.

The study aimed to deepen remission and achieve long-term responses.

Trial data showed that adding BLINCYTO to consolidation chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone.

The three-year OS rate was 84.8% for patients receiving BLINCYTO plus chemotherapy, versus 69% for those on chemotherapy alone.

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After four and a half years of median follow-up, the five-year OS was 82.4% in the BLINCYTO and chemotherapy arm versus 62.5% in the chemotherapy group.

Amgen research and development executive vice-president and chief scientific officer Jay Bradner stated: “B-ALL is an aggressive blood cancer with enduring high unmet need. BLINCYTO has helped thousands of patients with B-ALL over the last 10 years.

“The approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative first-in-class bispecific T-cell engager (BiTE) therapy.”

BLINCYTO, a (BiTE) immuno-oncology therapy targeting CD19 surface antigens on B cells, has obtained breakthrough therapy and priority review designations from the FDA.

It is already approved in the US for multiple indications such as CD19-positive B-ALL in first or second complete remission with MRD ≥0.1%, and relapsed or refractory CD19-positive B-ALL in adults and paediatric patients aged above one month.

In May 2024, Amgen‘s Bkemv (eculizumab-aeeb) received FDA approval for use as the first interchangeable biosimilar to Soliris (eculizumab) for the treatment of specific rare diseases.