Pink Sheet – Cell Therapy Development: White Paper Urges US FDA To Allow Some Shortcuts
A Friends of Cancer Research white paper argues that the use of pre-clinical, dosing and manufacturing data from Gilead Sciences, Inc./Kite Pharma’s Yescarta CAR-T therapy to support approval of the follow-on Tecartus provides a model for the US FDA to use in streamlining iterative product development of cellular therapies. “Yescarta and Tecartus provide an example of extrapolation in…