FDA cites in­creased death risk in de­ci­sion to yank ap­proval for TG Ther­a­peu­tics can­cer drug

Fol­low­ing pre­vi­ous­ly re­vealed safe­ty con­cerns, the FDA on Wednes­day said it has with­drawn TG Ther­a­peu­tics’ can­cer drug Ukoniq to treat two spe­cif­ic types of lym­phoma, mar­gin­al zone lym­phoma and fol­lic­u­lar lym­phoma.

The de­ci­sion comes as up­dat­ed find­ings from an on­go­ing tri­al of the drug, known gener­i­cal­ly as um­bral­is­ib, show an in­creased risk of death in pa­tients, and FDA said the risks of treat­ment with Ukoniq out­weigh its ben­e­fits.

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