Daily Newsletter

17 June 2024

Daily Newsletter

17 June 2024

FDA approves Amgen’s BLINCYTO for acute lymphoblastic leukaemia

The approval is based on the findings from the Phase III E1910 clinical trial.

Vishnu Priyan June 17 2024

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.

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.

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