Amgen’s Blincyto (blinatumomab) has been granted a licence extension by the Medicines and Healthcare products Regulatory Agency (MHRA) in acute lymphoblastic leukaemia (ALL).
The immunotherapy has been authorised for use in adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells.
Approximately 300 new adult cases of ALL, a type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, are diagnosed in the UK every year. B-cell ALL is the most common form of the disease, accounting for approximately 75% of cases in adults.
Despite the majority of patients being in remission after induction treatment, there is an unmet need for targeted treatments that reduce the number of remaining leukaemia cells that could cause a subsequent relapse, Amgen outlined.
Administered as an intravenous infusion and already approved in the UK to treat certain cases of B-ALL, Blincyto is a bispecific T-cell engager molecule designed to target CD19 surface antigens on B cells.
The MHRA’s latest decision on Blincyto, which follows the US Food and Drug Administration’s approval of the drug in the same indication in June, was supported by positive results from the late-stage E1910 trial led by the ECOG-ACRIN Cancer Research Group.
The study showed that Blincyto added to multiphase consolidation chemotherapy showed superior overall survival (OS) and relapse-free survival (RFS) compared chemotherapy alone in adults with Philadelphia chromosome negative CD19-positive B-ALL who were minimal residual disease negative.
With a median follow-up of 4.5 years, the five-year OS was 82.4% in the Blincyto plus chemotherapy cohort versus 62.5% in the chemotherapy group, while the five-year RFS was 77% in the Blincyto/chemotherapy arm versus 60.5% for chemotherapy alone.
Tony Patrikios, medical director, Amgen UK & Ireland, said: “B-cell ALL is a rare life-threatening blood cancer… The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse.”