MHRA approves Amgen's Blincyto for new acute lymphoblastic leukemia use

Amgen's innovative therapy, Blincyto (blinatumomab), has received an extended licence from the Medicines and Healthcare products Regulatory Agency (MHRA) for use in managing acute lymphoblastic leukaemia (ALL) in the UK. This development focuses on patients with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL, specifically during the consolidation phase of treatment. This phase is crucial as it aims to eliminate any lingering leukaemia cells after initial therapy.

In the UK, approximately 300 adults are diagnosed annually with ALL, a type of blood cancer originating in the bone marrow that can potentially spread throughout the body. The majority of these cases, about 75%, involve B-cell ALL, making it the most prevalent form of the disease in adults. Despite many patients achieving remission following induction treatment, there remains a significant need for targeted therapies to reduce residual leukaemia cells and minimize the risk of relapse.

Blincyto is already sanctioned for certain B-cell ALL cases in the UK and is administered via intravenous infusion. It functions as a bispecific T-cell engager, specifically targeting CD19 surface antigens found on B cells. The decision by the MHRA to extend Blincyto's licence follows a similar approval by the US Food and Drug Administration in June for the same indication.

The licence expansion is backed by compelling findings from the late-stage E1910 trial, conducted by the ECOG-ACRIN Cancer Research Group. The study provided evidence that Blincyto, when combined with multiphase consolidation chemotherapy, significantly enhances overall survival (OS) and relapse-free survival (RFS) compared to chemotherapy alone in adults with Philadelphia chromosome-negative CD19-positive B-ALL who are minimal residual disease negative.

The trial, which had a median follow-up duration of 4.5 years, demonstrated that the five-year OS rate was notably higher at 82.4% for patients receiving Blincyto in combination with chemotherapy, as opposed to 62.5% for those receiving only chemotherapy. Similarly, the five-year RFS was superior, with 77% in the Blincyto plus chemotherapy group compared to 60.5% in the group treated with chemotherapy alone.

Tony Patrikios, the medical director of Amgen UK & Ireland, emphasized the significance of this advancement: "B-cell ALL is a rare and life-threatening form of blood cancer. The consolidation phase involves intensive treatment and can be a particularly distressing period for patients and their families. This licence extension enables us to provide vital frontline treatments to more patients across the UK, aiming to lower the likelihood of disease relapse."

Blincyto's enhanced approval offers hope for improved outcomes for adults dealing with this challenging disease. The results from the E1910 trial underscore the potential of Blincyto as a crucial component of treatment regimens, offering a promising path forward for patients facing the uncertainties of consolidation therapy in ALL management. Through this licence extension, Amgen continues to make strides in addressing the treatment gaps in B-cell ALL, providing an important therapeutic option to mitigate relapse risks and improve survival rates for patients in the UK.