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Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication

2024-06-17

临床结果上市批准免疫疗法加速审批临床3期

Amgen’s Blincyto (blinatumomab) has been granted approval by the US Food and Drug Administration (FDA) to treat adult and paediatric patients aged one month and older with an aggressive type of blood cancer.

AmgenherBlincytobeblinatumomabd for use in patients with CD19-posUS Food and Drug Administration (FDA)e B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase, regardlblood cancerrable residual disease (MRD) status.

With more than 6,500 new cases diagnosed in the US last yCD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL)read to other parts of the body. B-ALL is the most common form of the disease, accounting for approximately 75% of cases in adults.

Administered as an intravenous infusion and already approved iALLhe US for two other B-ALL iblood cancerBlincyto is a bispecific T-cell engager (BiTE) immuno-oncology therapy designed to targB-ALL19 surface antigens on B cells.

The FDA’s latest decision was supported by positive results from the late-stage E1910B-ALLl led by the EBlincytoN Cancer Research Group, in which Blincyto added to multiphase consolidation chemoCD19apy showed superior overall survival (OS) against chemotherapy alone in patients with newly diagnosed Philadelphia chromosome-negative B-ALL.

The FDAee-year OS rate was 84.8% for those receiving Blincyto plus chemotherapy, compared to 69% in the chemotheraCancer. At a median follow-up ofBlincytors, the five-year OS was 82.4% in the Blincyto/chemotherapy cohort and 62.5% in the chemotherapy group.Philadelphia chromosome-negative B-ALL

Jay Bradner, executive vice president, research and dBlincytont, and chief scientific officer at Amgen, said: “Blincyto has helped thousands of patients with B-ALL over the last ten years. [ThBlincytooval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class BiTE therapy.”

The authorisation comes just a few weeks after Amgen’s Bkemv (eculizumab-aeeb) was approved by thAmgen as the fBlincytoerchangeable biosimilar to AstraZeneca’B-ALLiris (eculizumab) for two rare diseases characterised by the breakdown of red blood cells.

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