NICE Approves Autolus’ Obe-cel CAR-T Therapy for Adults with Rare Blood Cancer | iPharmaCenter

Hundreds of adults in England living with a rare and aggressive form of blood cancer could soon access a potentially life-saving therapy, following new guidance from the National Institute for Health and Care Excellence (NICE).

NICE has recommended obecabtagene autoleucel, also known as obe-cel or Aucatzyl, for routine NHS use in patients aged 26 and over with relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL). The decision marks an important step forward for approximately 150 people expected to be eligible over the next three years—many of whom currently have limited treatment options.

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Developed by Autolus, a spin-out company from University College London, obe-cel is a next-generation chimeric antigen receptor T-cell (CAR-T) therapy. The treatment involves reprogramming a patient’s own immune cells to identify and destroy cancer cells. Compared with earlier CAR-T therapies, obe-cel has shown reduced toxicity and a strong potential to induce remission, making it suitable for a broader range of patients.

Clinical trial data have demonstrated promising outcomes. In a study involving around 100 participants, 77% of those who received at least one infusion of obe-cel achieved remission. Evidence also suggests that patients treated with obe-cel may live longer than those treated with other immunotherapies typically used at this stage of the disease. The therapy performs comparably to tisagenlecleucel—the CAR-T therapy already available for younger patients aged 25 or under—but is now an option for adults beyond this age group.

When assessing obe-cel, NICE’s independent committee placed additional value on the substantial benefits it offers relative to current therapies, given the severity and poor prognosis of relapsed or refractory B-cell ALL.

The approval aligns with the UK government’s “Plan for Change” initiative, which aims to enhance access to innovative treatments and strengthen the NHS through innovation and cutting-edge research. The development and evaluation of obe-cel were supported by the National Institute for Health and Care Research (NIHR) and the UCLH Biomedical Research Centre, with clinical trials conducted across multiple UK sites.

B-cell acute lymphoblastic leukaemia remains a rare condition in the UK, affecting fewer than 5 in 10,000 people, but advances like obe-cel are set to reshape therapeutic options for adults battling this challenging disease.