FDA’s top cancer leaders want to shift how companion diagnostics are regulated

The FDA is rec­og­niz­ing a ma­jor dis­con­nect for some new can­cer drugs. This idea that each new on­col­o­gy drug ap­proved is aligned at the time of ap­proval with one di­ag­nos­tic test to se­lect pa­tients for the safe and ef­fec­tive use of the treat­ment is not what’s hap­pen­ing, “prac­ti­cal­ly speak­ing,” says Harpreet Singh, di­vi­sion di­rec­tor at FDA’s On­col­o­gy Cen­ter for Ex­cel­lence (OCE).

In­stead, in the re­al world, “mul­ti­ple lo­cal­ly-de­vel­oped tests are be­ing used” to en­roll pa­tients in tri­als, and those tests are large­ly un­reg­u­lat­ed. So by the time the clin­i­cal da­ta ar­rives at FDA, she said, “of­ten we do not have the ap­pro­pri­ate, and the amount of pa­tient sam­ples to bridge all of the lo­cal tests that were used to this one cen­tral di­ag­nos­tic test.”

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