Near­ly half of can­cer drugs grant­ed ac­cel­er­at­ed ap­proval didn’t end up show­ing clin­i­cal ben­e­fit — study

Al­most half of can­cer drugs that re­ceived ac­cel­er­at­ed ap­proval didn’t end up im­prov­ing qual­i­ty of life or sur­vival af­ter five years of fol­low-up, Har­vard Uni­ver­si­ty re­searchers found, un­der­scor­ing the un­cer­tain­ty around a com­mon­ly used reg­u­la­to­ry path­way for the treat­ments.

In a pa­per pub­lished in JA­MA Sun­day, the re­searchers from Har­vard’s Pro­gram on Reg­u­la­tion, Ther­a­peu­tics and Law looked at 129 can­cer drugs grant­ed ac­cel­er­at­ed ap­proval be­tween 2013 and 2023. On­col­o­gy drugs make up 80% of all ac­cel­er­at­ed ap­provals, the re­searchers not­ed.

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