Autolus's obecabtagene autoleucel (obe-cel) application in relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia (ALL) expected to be submitted to the EMA in first half of 2024

Autolus has confirmed its intent to submit an Marketing Authorization Application for obecabtagene autoleucel (obe-cel) for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) to the EMA in the first half of 2024.

This confirmation comes amid the announcement of the submisson Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the same indication. The BLA submission is based on data from the Pivotal Phase 2 FELIX study of obe-cel in adult r/r B-ALL.

Obe-cel was granted a PRIME designation by the EMA in 2021.

Reference link: Autolus press release