Cit­ing too many da­ta con­founders, FDA ad­comm unan­i­mous­ly votes against Y-mAb­s' drug for rare brain can­cer

On Fri­day af­ter­noon, the FDA’s on­col­o­gy drug ad­vi­so­ry com­mit­tee unan­i­mous­ly vot­ed 16-0 against the ap­proval of Y-mAbs’ ex­per­i­men­tal drug for CNS metas­tases in pe­di­atric neu­rob­las­toma pa­tients. The key is­sue the FDA point­ed to was that the ex­ter­nal con­trol group for Y-mAbs’ piv­otal study was very dif­fer­ent from the treat­ment group at base­line, an is­sue it high­light­ed in brief­ing docs re­leased yes­ter­day.

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