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)
Copyright (c) 2024 Dow Jones & Company, Inc.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.