Io­vance’s reg­is­tra­tional lung can­cer tri­al on hold af­ter pa­tient death

The FDA placed a clin­i­cal hold on a reg­is­tra­tional tri­al of Io­vance Bio­ther­a­peu­tics’ tu­mor-in­fil­trat­ing lym­pho­cyte, or TIL, ther­a­py LN-145 af­ter a pa­tient death in the study.

The hold puts a dent in the de­vel­op­ment of Io­vance’s sec­ond-most ad­vanced treat­ment can­di­date, and in­vestors sent its shares $IO­VA down more than 20% at Wednes­day’s open­ing bell. Io­vance had ex­pect­ed to com­plete en­roll­ment in the sec­ond half of next year in the hopes of fil­ing for ap­proval in post-an­ti-PD-1 non-small cell lung can­cer, or NSCLC, it said in No­vem­ber.

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