Autolus Therapeutics Gets BLA Acceptance for Obecabtagene Autoleucel
22 January 2024 - 11:54PM
Dow Jones News
By Chris Wack
Autolus Therapeutics said that the U.S. Food and Drug
Administration has accepted its Biologics License Application for
obecabtagene autoleucel for patients with relapsed/refractory Adult
B-Cell acute lymphoblastic leukemia.
Under the Prescription Drug User Fee Act, the FDA has set a
target action date of Nov. 16.
The FDA isn't currently planning to hold an advisory committee
meeting to discuss this application.
The BLA submission is based on data from a Phase 2 study of
obe-cel in adult r/r B-ALL.
Autolus plans to submit a Marketing Authorization Application
for obe-cel in relapsed/refractory ALL to the European Medicines
Agency in the first half of 2024.
Obe-cel has been granted Orphan Drug Designation by the FDA and
Orphan Medical Product Designation by the EMA.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 22, 2024 07:39 ET (12:39 GMT)
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