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Cell Therapy Development: White Paper Urges US FDA To Allow Some Shortcuts

 
• By Michael McCaughan

A Friends of Cancer Research working group suggests that the US FDA can learn lessons from the approval of Gilead/Kite’s second CAR-T therapy Tecartus that can help expedited iterative development of cell therapies more broadly.

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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 engineered cellular therapy products,” the white paper says. Yescarta (axicabtagene ciloleucel) was one of the first CAR-T anticancer therapies approved by FDA in 2017

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