NICE has issued draft guidance recommending Autolus Therapeutics’ CAR‑T therapy AUCATZYL (obecabtagene autoleucel) for adult patients aged 26 and older with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (r/r B‑ALL) in England and Wales. The guidance, published on November 25 2025, authorises routine NHS commissioning of the drug in these regions.
The recommendation follows the UK Medicines and Healthcare products Regulatory Agency’s conditional marketing authorisation granted in April 2025. AUCATZYL carries a list price of £372,000 per infusion, with a confidential discount applied to NHS budgets. NICE estimates that roughly 150 patients will be eligible for treatment over the next three years, a figure that underscores the therapy’s potential impact on a relatively small but high‑need patient cohort.
AUCATZYL competes with existing r/r B‑ALL options such as ponatinib, inotuzumab ozogamicin, blinatumomab, and tisagenlecleucel, as well as other CAR‑T products like Novartis’ Kymriah and Gilead/Kite’s Tecartus. Clinical data from the FELIX trial show a 77 % remission rate and a safety profile that appears less toxic than earlier CD19 CAR‑T therapies, positioning AUCATZYL as a next‑generation alternative for patients who are ineligible for younger‑age CAR‑T products.
Autolus’ strategy to launch AUCATZYL in the UK hinges on this regulatory milestone. The company’s Q3 2025 financials revealed a net loss of $79.1 million and revenue of $21.1 million, with cash reserves falling to $367.4 million from $588 million at the end of 2024. The company’s Altman Z‑Score of –2.57 signals a heightened bankruptcy risk, highlighting the critical importance of successful commercialization in the UK to offset ongoing R&D and commercialization expenses.
Dr. Christian Itin, Autolus CEO, said, “AUCATZYL represents an important new treatment option for eligible adult r/r B‑ALL patients. NHS clinical centres and UK patients participated in the development of AUCATZYL, and we are looking forward to supporting patients and physicians in England and Wales now with the commercial product.”
The NICE recommendation marks a significant step toward broader access for a therapy that could improve remission rates for a niche but severe disease. For Autolus, the approval opens a new revenue stream in the UK, a key market for CAR‑T therapies, and provides a foundation for future expansion into other indications and geographies.
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