Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, describes recent approvals and developments within the advanced therapy space, including the FDA approval of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell therapy, in patients with relapsed/refractory multiple myeloma. Dr Levine additionally highlights developments in tumor-infiltrating lymphocytes (TILs), as well the need to focus on Chemistry, Manufacturing, and Control (CMC) standards within the regulatory process. This interview took place at Advanced Therapies Week 2022.
Bruce Levine reports consultancy fees from Terumo, GSK; is part of the Scientific Advisory Board for Akron, Avectas, Immuneel, Immusoft, In8bio, Ori Biotech, Oxford Biomedica, and Vycellix; and is the Co-Founder and equity holder Tmunity Therapeutics, and Capstan Therapeutics. Conflict of interest is managed in accordance with University of Pennsylvania policy and oversight.