Blinatumomab approved for acute lymphoblastic leukaemia (ALL) patients

Webpage last updated on: 8th September 2025

What’s the news?

If you or a loved one are living with B-cell acute lymphoblastic leukaemia (ALL), we’re pleased to share that the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) have officially approved blinatumomab as a treatment option, following its appraisal meeting in January 2025 and August 2025, respectively. This approval represents a major step forward in access to blinatumomab, as access before was restricted to a certain group of patients.

What this approval means for you

NICE and the SMC’s approval makes blinatumomab more widely available through the NHS, meaning you could now have access to this cutting-edge treatment. Previously, access was limited to those who had relapsed or refractory ALL and had tried at least two prior therapies. It was also available in those who had measurable residual disease (also known as MRD positive). This means a person is already seeing signs of leukaemia cells in their body and is therefore at a higher risk of leukaemia returning.

This expansion of eligibility is a welcome development, as research into your quality of life has shown that relapse is a highly stressful time for patients and their loved ones. Blinatumomab can now be given as maintenance treatment, a form of treatment that is designed to prevent relapse from happening at all.

“For families dealing with the devastating impact of ALL, the approval of blinatumomab represents a beacon of hope,” said Colin Dyer, CEO of Leukaemia Care. “This decision provides a new tool in the ongoing fight against leukaemia, helping us to avoid relapse and its devastating impact on patients.” 

What is Blinatumomab?

Blinatumomab, marketed under the brand name Blincyto, is a bispecific T-cell engager (BiTE) therapy. It works by activating your immune system to recognise and eliminate leukaemia cells. Blinatumomab attaches to two different targets: CD19, a protein on the surface of B-cell leukaemia cells, and CD3, a protein on your immune system’s T-cells. This connection helps your immune system directly attack the cancerous B-cells, instead of relying on the T cells finding the leukaemia cells by chance.

How Blinatumomab could help you

NICE and the SMC approved blinatumomab based on strong evidence from clinical trials showing high remission rates, even in difficult-to-treat cases. Unlike some other treatments, blinatumomab has been shown to offer remission with a manageable side effect profile, helping you maintain a better quality of life while fighting leukaemia. In some cases, blinatumomab can be given at home with outpatient appointments.

The Acute Leukaemia Advocates Network (ALAN), an international organisation of which Leukaemia Care is a member, published the key paper in 2021 that demonstrated the need for more access to blinatumomab. They found that relapse is an event that is most likely to lead to poor quality of life in patients with acute leukaemia, and this negative impact is maintained even when people recover. Therefore, avoiding relapse from happening at all is preferable.

Support from Leukaemia Care for this decision

Leukaemia Care played a key role in advocating for blinatumomab to be an option for you and your doctors. By sharing your experiences both in writing and in person, we helped highlight the need for improved access to therapies like blinatumomab. Our ability to advocate for new treatments like this is only possible thanks to your engagement with surveys, advisory panels and stories, for which we are grateful.