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With eyes on manufacturing, Iovance’s TIL therapy reaches long-awaited, world-first approval 

ARTICLE | Regulation

Therapy will be made at the biotech’s Philadelphia facility and a nearby CDMO, with plans to serve ‘up to several thousand patients annually’

By Karen Tkach Tuzman, Director of Biopharma Intelligence

February 17, 2024 2:10 AM UTC

Having reached a regulatory milestone decades in the making, tumor-infiltrating lymphocyte cancer therapies must now prove they can scale.

More than 30 years after NCI trials showed therapeutic effects of autologous T cells isolated from tumor tissues and expanded ex vivo, FDA’s accelerated approval of Amtagvi lifileucel from Iovance Biotherapeutics Inc. (NASDAQ:IOVA) makes it the first TIL therapy on the market, and the agency’s first approval of a T cell therapy for solid tumors…