Autolus Therapeutics Gets FDA Approval for Cancer Treatment

Dow Jones

Nov 09, 2024

By Connor Hart

Autolus Therapeutics said it received Food and Drug Administration approval of its treatment of acute lymphoblastic leukemia, or ALL, an aggressive blood and bone marrow cancer, for certain patients.

The treatment, called Aucatzyl, has been granted marketing approval for the treatment of adult patients with relapsed or refractory B-cell precursor ALL, the London biopharmaceutical company said Friday.

Its approval was based on the results of a clinical study in which 42% of patients with the cancer achieved complete remission within three months.

"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, the trial's lead investigator.

Chief Executive Christian Itin said the treatment marks Autolus' first commercial product. In addition to its U.S. approval, marketing authorization applications are being reviewed by the regulators in the European Union and the United Kingdom, the company said.

Shares rise 1.3%, to $3.78, in after-hours trading.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

November 08, 2024 17:38 ET (22:38 GMT)

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