MHRA backs Aucatzyl for lymphoblastic leukemia

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) late Friday announced it has granted a conditional marketing authorization for the Aucatzyl (obecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The new conditional marketing authorization was granted to UK-based Autolus Therapeutics (Nasdaq: AUTL).

“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 of Autolus, adding: “We want to thank all the patients and investigators at the UK trial centers for their contributions towards this license, as well as the foundational work by our partners at UCL and our internal team.”