MHRA Approves Autolus' Aucatzyl for Acute Lymphoblastic Leukaemia

The Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally approved Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukaemia (ALL) in adults. This CAR T-cell therapy is specifically meant for patients with relapsed or refractory (R/R) B-cell precursor ALL.

Acute lymphoblastic leukaemia is a severe form of blood cancer, and each year approximately 765 new cases are identified in the UK. Despite initial treatments, about half of the patients experience a relapse, and the survival rates for adults with R/R ALL are notably low. Aucatzyl offers a novel approach to treatment by employing an intravenous infusion method. The therapy modifies patients' T cells into CD19-targeting CAR T cells. These engineered cells, when reintroduced into the patient, are capable of identifying and eliminating cancerous cells.

The MHRA's decision to approve Aucatzyl was based on data from the FELIX trial, an open-label study. In this trial, 94 patients with R/R B-cell ALL received at least one infusion of Aucatzyl. Remarkably, 52 of these patients achieved complete remission, and the probability of overall survival at 12 months was estimated at 81%.

Julian Beach, the interim executive director of healthcare quality and access at the MHRA, emphasized the agency's dedication to swiftly providing patients with innovative treatments like CAR T-cell therapy. He assured that their approval is grounded in strong evidence of efficacy and the highest safety standards. Beach stated that the regulatory benchmarks for this medicine's approval were satisfactorily met.

Under the conditional marketing authorisation framework, the MHRA will continue to assess new efficacy and safety data for Aucatzyl at least annually. Meanwhile, the National Institute for Health and Care Excellence (NICE) is currently evaluating the therapy's potential incorporation into NHS treatment options.

Claire Roddie, the lead investigator of the FELIX trial at the University College London Cancer Institute, expressed her enthusiasm about the progress towards making Aucatzyl accessible to eligible R/R B-cell ALL patients. Roddie highlighted the significance of NICE's forthcoming assessment, which could pave the way for the therapy to be available to patients through the NHS.

This development in the treatment of acute lymphoblastic leukaemia represents a significant stride forward. The approval of Aucatzyl offers hope to patients with limited treatment options and underscores the importance of ongoing research and innovation in tackling aggressive forms of cancer. The medical community eagerly awaits further evaluations, which, if favorable, could make this therapy a standard option for those battling this challenging disease.