Annie Lennon
The National Institute for Health and Care Excellence (NICE) has recommended obecabtagene autoleucel (obe-cel) for adults aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
More than 150 people in England and Wales are expected to receive the new treatment over the next 3 years as a result of the final draft guidance.
Obe-cel (Aucatzyl) was developed by Autolus, a University College London spinout company. It received a conditional marketing authorisation from the Medicines and Healthcare products Regulatory Agency in April 2025.
Comparative data remain uncertain. However, early findings indicate improved survival compared with blinatumomab, inotuzumab ozogamicin, or ponatinib. Its efficacy appears similar to tisagenlecleucel, typically offered to people aged 18-25.
“This drug has the potential to offer a more effective and less toxic alternative to standard treatments, with fewer side effects,” said Helen Knight, director of medicines evaluation at NICE. “This could potentially be a life-saving drug, which will make a huge difference to people's lives including spending less time in hospital.”
ALL is a rare and rapidly progressing blood cancer caused by the overproduction of lymphoblasts in the bone marrow. This leads to abnormal blood cell production and disrupts normal haematopoiesis.
Around 45% of adults experience relapse or refractory disease. Philadelphia-chromosome-positive B-cell ALL is more common in adults and carries a higher risk of progression. Fewer than 5 in 10,000 people in the UK are affected.
Obe-cel is a genetically modified autologous T-cell immunotherapy. It uses a patient’s own T cells, engineered to express chimeric antigen receptors that bind to CD19 surface markers on malignant B cells. This binding triggers anti-tumour activity by killing CD19-expressing cells.
The key evidence for obe-cel comes from the ongoing FELIX study, a single-arm, phase 1b/2, non-randomised, open-label trial. It includes 153 adults with relapsed or refractory B-cell ALL across five cohorts.
The company identified cohort 2A as being most relevant for committee evaluation. It included 112 patients, with 94 receiving at least one infusion. A November 2024 publication reported that, after a median follow-up of 20.3 months, 77% achieved overall remission and 55% achieved complete remission.
During evaluation, the company submitted data up to January 2025. Median overall survival was confidential, but the committee deemed the evidence adequate for decision-making.
As of January 2025, the most common treatment-emergent adverse events were cytokine release syndrome, pyrexia, and anaemia. Most were considered low grade.
A bone marrow assessment within seven days of starting lymphodepleting chemotherapy is required to determine the dose. Obe-cel is administered at 410 × 106CD19 CAR-positive viable T cells in three or more infusion bags.
The list price is £372,000 per infusion. The therapy will be available only through a confidential commercial arrangement.
Full clinical details are available in the product’s summary of product characteristics.
Annie Lennon is a medical journalist. Her writing appears on Medscape, WebMD, and Medical News Today, among other outlets.
Send comments and news tips to uknewsdesk@medscape.co.uk.
Related Article
