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.
The therapy has been authorised for use in patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
With more than 6,500 new cases diagnosed in the US last year, ALL is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread 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 in the US for two other B-ALL indications, Blincyto is a bispecific T-cell engager (BiTE) immuno-oncology therapy designed to target CD19 surface antigens on B cells.
The FDA’s latest decision was supported by positive results from the late-stage E1910 trial led by the ECOG-ACRIN Cancer Research Group, in which Blincyto added to multiphase consolidation chemotherapy showed superior overall survival (OS) against chemotherapy alone in patients with newly diagnosed Philadelphia chromosome-negative B-ALL.
The three-year OS rate was 84.8% for those receiving Blincyto plus chemotherapy, compared to 69% in the chemotherapy arm. At a median follow-up of 4.5 years, the five-year OS was 82.4% in the Blincyto/chemotherapy cohort and 62.5% in the chemotherapy group.
Jay Bradner, executive vice president, research and development, and chief scientific officer at Amgen, said: “Blincyto has helped thousands of patients with B-ALL over the last ten years. [This] approval 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 the FDA as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) for two rare diseases characterised by the breakdown of red blood cells.
The company also received accelerated approval from the US regulator last month for its immunotherapy Imdelltra (tarlatamab-dlle) to treat