Autolus Therapeutics announces license issued by UK MHRA for adult patients
London, 25 April 2025 -Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, announces today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL).
“Having treated a number of patients with AUCATZYL as part of the FELIX clinical trial, I am delighted that we have moved closer to eligible relapsed/refractory B-ALL patients being able to access AUCATZYL,” said Dr. Claire Roddie, MD, PhD, FRCPath, Lead investigator of the FELIX study and Associate Professor of Haematology at the University College London (UCL) Cancer Institute. “We now look forward to NICE completing its assessment of the medicine to potentially make it an option for eligible patients on the NHS.”
“AUCATZYL was designed to address an unmet need for eligible adult r/r B-ALL patients and it is satisfying that is has been licensed in the country where it was created,” said Dr. Martin Pule, Chief Scientific Officer and Founder of Autolus.
“Continuing our momentum, this MHRA license is a significant milestone for Autolus as a company. With our scientific expertise, operations and manufacturing based in the UK, this is an important achievement for our company,” said Dr. Christian Itin, Chief Executive Officer of Autolus. He continued:
We want to thank all the patients and investigators at the UK trial centres for their contributions towards this license, as well as the foundational work by our partners at UCL and our internal team.
Obecabtagene autoleucel is an autologous CD19 CAR T cell therapy with a proprietary CD19 CAR, invented by a team led by Dr. Martin Pule, at University College London, along with collaborators at Great Ormond Street Hospital and University College London Hospital. The CAR is designed to have a “fast-off” rate which mimics physiological T-cell receptor interactions.
Autolus submitted obecabtagene autoleucel for appraisal by the National Institute for Health and Care Excellence (NICE) in Q4 2024 and is working with NICE and the NHS to potentially achieve access for eligible patients in England. NICE provides guidance to the NHS in England on the clinical and cost-effectiveness of medicines, treatments, and technologies based on a rigorous process of evidence review and consultation with professionals and patients.
ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. In the UK there are approximately 765 new cases of ALL diagnosed every year. In frontline treatment for adult B-ALL, up to 50% of patients will ultimately relapse. Survival rates remain very poor in adult patients with r/r ALL, with median overall survival of eight months with conventional treatments, and the standard-of-care treatment can trigger severe toxicities.
