When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Al­though it’s ex­ceed­ing­ly rare for the FDA to re­scind a break­through des­ig­na­tion once it’s grant­ed, there has been a re­cent uptick — as in 2020 and 2021 com­bined, the agency re­scind­ed 17 BTDs, com­pared to just 18 re­scind­ed from 2015 to 2019 com­bined.

Pro­tag­o­nist Ther­a­peu­tics saw this re­al­i­ty up close and per­son­al in April af­ter a clin­i­cal hold lift­ed on its ex­per­i­men­tal blood can­cer drug, as the com­pa­ny re­vealed that the FDA sought to re­voke the BTD. The de­ci­sion, Pro­tag­o­nist says, stems from “ob­served ma­lig­nan­cies” re­lat­ed to the hold, ini­tial­ly im­posed in Sep­tem­ber 2021.

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