Precision BioSciences announced that the U.S. Food and Drug Administration (FDA) provided supportive Type C feedback on the Company's CMC processes and analytical methods for azercabtagene zapreleucel (azer-cel; PBCAR0191). Azer-cel is Precision BioSciences lead allogeneic CAR T candidate being evaluated for relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) in subjects who have relapsed following autologous CAR T treatment.
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- Precision BioSciences Receives Favorable Type C Feedback from the FDA on the Company’s Chemistry, Manufacturing, and Controls Strategies for Late-Stage Development of Azercabtagene Zapreleucel, Its Lead Allogeneic Car T Clinical Candidate