FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s On­col­o­gy Cen­ter of Ex­cel­lence has been a bright spot with­in the agency in terms of speed­ing new treat­ments to pa­tients. That flex­i­bil­i­ty was on full dis­play this morn­ing as FDA re­leased new draft guid­ance spelling out ex­act­ly how on­col­o­gy drug de­vel­op­ers can ful­fill both the ac­cel­er­at­ed and full ap­proval’s re­quire­ments with just a sin­gle ran­dom­ized con­trolled tri­al.

While Con­gress re­cent­ly passed leg­is­la­tion that will al­low FDA to re­quire con­fir­ma­to­ry tri­als to be re­cruit­ing and on­go­ing pri­or to grant­i­ng an ac­cel­er­at­ed ap­proval, the agency is now mak­ing clear that the ini­tial tri­al used to win the AA, if de­signed ap­pro­pri­ate­ly, can al­so serve as the tri­al for con­vert­ing the ac­cel­er­at­ed ap­proval in­to a full ap­proval.

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