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# Precision BioSciences to Meet with FDA on Azer-Cel
- URL: https://www.fdaweb.com/precision-biosciences-to-meet-with-fda-on-azer-cel/
- Published: 2023-05-31T12:00:00.000Z
- Updated: 2026-09-14T18:35:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154575

Based on positive results from the latest trial of Precision BioScience’s azercabtagene zapreleucel (azer-cel) as a potential first-in-class allogeneic CD 19 CAR T for the growing CAR T relapsed patient population with diffuse large B-cell lymphoma (DLBCL), the company has scheduled a June meeting with FDA officials to align on a potential Phase 2 study in CAR T relapsed DLBCL patients, with a focus on trial design, site, and endpoints. A company statement says it believes it has identified the recommended azer-cel dosing regimen to discuss in the meeting.

The statement says azer-cel achieved an 83% overall response rate and 61% complete response rate, with 55% durable response greater than or equal to six months among evaluable CAR T relapsed subjects.