The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel) to treat acute lymphoblastic leukaemia (ALL).
The CAR T-cell therapy has been specifically authorised for use in adults with relapsed or refractory (R/R) B-cell precursor ALL.
Approximately 765 new cases of ALL, an aggressive blood cancer, are diagnosed in the UK every year. Up to 50% of patients will relapse following frontline treatment, and survival rates remain very poor in adults with R/R disease.
Administered as an intravenous infusion, Aucatzyl works by taking patients’ T cells and transforming them into CD19-targeting CAR T cells. When transferred back into the body, these modified cells can recognise and destroy the cancer cells.
The MHRA’s decision on the therapy was supported by data from the open-label FELIX trial, in which 52 of the 94 R/R B-cell ALL patients who were given at least one infusion of Aucatzyl showed complete remission of the disease with an 81% probability of overall survival at 12 months.
Julian Beach, MHRA interim executive director, healthcare quality and access, said: “We are committed to making innovative treatment options, like CAR T-cell therapy, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety.
“We are assured that the appropriate regulatory standards for the approval of this medicine have been met.”
In line with its conditional marketing authorisation pathway, the MHRA will review new efficacy and safety information for Aucatzyl at least once every year.
The therapy is now being evaluated by the National Institute for Health and Care Excellence (NICE) for potential use on the NHS.
FELIX lead investigator, Claire Roddie, University College London Cancer Institute, said: “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 R/R B-cell ALL patients being able to access Aucatzyl.
“We now look forward to NICE completing its assessment of the medicine to potentially make it an option for eligible patients on the NHS.”
