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.