FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Un­cer­tain­ty about clin­i­cal tri­al ev­i­dence has led the FDA to hand down a com­plete re­sponse let­ter for Y-mAbs’ neu­rob­las­toma drug, cast­ing a cloud on the fu­ture of a can­di­date that had gone through a long de­vel­op­ment jour­ney in a rare pe­di­atric can­cer.

Y-mAbs said it’s dis­ap­point­ed “but not sur­prised” giv­en that the agency’s on­col­o­gy drug ad­vi­so­ry com­mit­tee had vot­ed 16-0 against its drug’s ap­proval a few weeks ago.

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