The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for obecabtagene autoleucel (Aucatzyl)—a CAR T-cell therapy—for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL).

Refractory B-cell precursor acute lymphoblastic leukemia, is a type of aggressive blood cancer that is caused by uncontrollable production of large amounts of immature B-lymphocytes & tends to not respond to initial treatment making a challenging case.  

Obecabtagene autoleucel is a type of immunotherapy that works by extracting the patient’s own immune cells specifically “T cells” and gets reinjected after modification making them able to identify cancerous cells and kill them.

The approval is based on results from the ongoing FELIX study, which included 153 adults with relapsed or refractory B-ALL. 52 of the 94 patients who received the treatment, more than half achieved complete remission. The study also showed an 81% chance of survival at 12 months.

Common side effects include nausea, headache, dizziness, fever, low blood pressure, and temporary brain function changes. The medicine is given as an IV infusion in a specialized clinical setting by trained doctors.

As with all medicines, the MHRA will continue to closely monitor the safety and effectiveness of obecabtagene autoleucel.

If you experience any side effects, speak with your doctor, pharmacist, or nurse. You can also report them directly through the Yellow Card scheme.

Learn more: Obecabtagene autoleucel conditionally approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia - GOV.UK