Autolus Therapeutics has been granted marketing approval from the FDA for its CAR-T therapy, Aucatyzl.
The cell and gene therapy is designed to treat adult patients with relapsed/refractory B-celll precursor acute lymphoblastic leukaemia (R/R B-ALL).
Aucatzyl gained FDA approval through the results of the FELIX clinical trial, which exhibited obe-cel's potential in treating the condition.
During the trial, Aucatzyl demonstrated overall complete remission in 63% of efficacy evaluable patients.
Complete remission was seen within three months in 42% of patients, with the mean remission period standing at 14.1 months.
The CAR-T therapy also exhibited low levels of cytokine release syndrome — a common side effect associated with this genre of cell and gene therapies.
"Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes," said Elias Jabbour, US lead investigator of the FELIX study and professor of Leukemia, ALL Section Chief, at The University of Texas MD Anderson Cancer Center.
"This milestone approval, based on the demonstrated clinical benefit of AUCATZYL, brings new hope for adult patients with relapsed/refractory B-ALL."
Autolus to manufacture Aucatzyl
Aucatzyl will be manufactured at Autolus' dedicated commercial manufacturing site in Stevenage, UK.
The site has been granted a Manufacturer's Importation Authorisation (MIA), as well as a GMP cerificate from the MHRA.
Autolus will now engage with existing treatment centers to complete the onboarding process and initiate the first scheduling of patients to make AUCATZYL commercially available in the US.
Marketing authorisation applications (MAAs) are also being reviewed by regulators in the EU and UK.
"Based on the experience in the FELIX trial AUCATZYL is highly active and can be well managed, offering an attractive risk benefit profile for B-ALL patients." said Dr. Claire Roddie, Lead investigator of the FELIX study and Associate Professor of Haematology at the University College London (UCL) Cancer Institute.
"In the FELIX trial, AUCATZYL has shown long term persistence and deep responses which we believe are critical for long term remissions in B-ALL."
[Image credit: Prof. Osaro Erhabor]