FDA ‘re-eval­u­at­ing’ ap­provals for TG Ther­a­peu­tics’ can­cer drug af­ter find­ing pos­si­ble in­creased risk of death

The FDA said late last week that due to the pos­si­ble in­creased risk of death in pa­tients tak­ing TG Ther­a­peu­tics’ can­cer drug Ukoniq (um­bral­is­ib) in a clin­i­cal tri­al, the agency is now “re-eval­u­at­ing this risk against the ben­e­fits of Ukoniq for its ap­proved us­es.”

The news comes as TG’s CEO re­cent­ly re­vealed this “par­tial clin­i­cal hold” at an in­vestor con­fer­ence, telling at­ten­dees that the study re­lat­ed to the com­bi­na­tion of Ukoniq and an an­ti-CD20 mon­o­clon­al an­ti­body to treat chron­ic lym­pho­cyt­ic leukemia and non-Hodgkin’s lym­phoma.

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