FDA should re­assess post­mar­ket tri­als for can­cer drugs ap­proved via ac­cel­er­at­ed path­way, re­searchers say

The FDA may need to re­assess how con­fir­ma­to­ry tri­als are con­duct­ed af­ter just one-fifth of such tri­als for can­cer drug in­di­ca­tions ap­proved via the FDA’s ac­cel­er­at­ed ap­proval path­way have demon­strat­ed im­prove­ments in over­all sur­vival (OS), re­searchers re­port­ed Tues­day in JA­MA In­ter­nal Med­i­cine re­search.

The re­searchers looked at 93 can­cer drug in­di­ca­tions grant­ed ac­cel­er­at­ed ap­proval by the FDA from 1992 through May 2017, find­ing con­fir­ma­to­ry tri­als re­port­ed that 20% had im­prove­ment in over­all sur­vival, 21% had im­prove­ment in a dif­fer­ent sur­ro­gate mea­sure and 20% had im­prove­ment in the same sur­ro­gate mea­sure used in con­fir­ma­to­ry tri­als and preap­proval tri­als.

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