EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Aucatzyl (obecabtagene autoleucel) to treat adults from 26 years of age with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (B ALL).
Acute lymphoblastic leukaemia (ALL) is a fast-growing and life-threatening cancer that affects the blood and bone marrow, specifically impacting white blood cells (lymphocytes). Relapsed ALL comes back after treatment, and refractory ALL does not respond to initial treatment. Despite multiple available therapeutic options, this condition is associated with significant mortality and a poor survival rate.
Aucatzyl is a genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, a type of personalised cancer immunotherapy that is based on collecting and modifying the patient’s own immune cells to treat their cancer. The modified T cells attach to and kill the cancer cells, thereby helping to clear the cancer from the body.
Aucatzyl was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs…
