FDA rais­es ef­fi­ca­cy con­cerns with Y-mAb­s' po­ten­tial ther­a­py for pe­di­atric neu­rob­las­toma ahead of ODAC meet­ing

Ahead of a key meet­ing of the FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee to­mor­row, the FDA is rais­ing se­ri­ous con­cerns re­gard­ing the ef­fi­ca­cy of Y-mAbs Ther­a­peu­tics’ po­ten­tial pe­di­atric neu­rob­las­toma treat­ment.

Part of the prob­lem for FDA is that the en­tire ap­pli­ca­tion for 131I-om­bur­tam­ab is based on a small, sin­gle-arm tri­al from New York’s Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter that found the three-year over­all sur­vival rate af­ter CNS/LM re­lapse in the ef­fi­ca­cy pop­u­la­tion of 94 pa­tients was 54%.

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