Two years af­ter a refuse-to-file, Y-mAbs lands an FDA ad­comm for its 2nd neu­rob­las­toma treat­ment

Y-mAbs Ther­a­peu­tics is look­ing to cap­i­tal­ize on a sec­ond chance at win­ning ap­proval for its po­ten­tial treat­ment of pe­di­atric neu­rob­las­toma with CNS/cere­brospinal flu­id can­cer as the FDA has set up an ad­comm meet­ing of out­side ex­perts for Oct. 28 to re­view the ap­pli­ca­tion.

First de­vel­oped by Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter and li­censed to Y-mAbs, om­bur­tam­ab is one of the com­pa­ny’s two lead com­pounds fo­cused on neu­rob­las­toma, an area with high un­met need.

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