TG Ther­a­peu­tics scores con­di­tion­al FDA go-ahead for a drug it's pitch­ing as a safer PI3K

Safe­ty is­sues have long been a sore spot for the PI3K on­col­o­gy mar­ket, and some of the biggest phar­ma play­ers have walked away. But TG Ther­a­peu­tics has ar­gued it has a safer al­ter­na­tive on its hands, and now the FDA is giv­ing it a con­di­tion­al green light to try and shake up the mar­ket.

The FDA on Fri­day ap­proved TG Ther­a­peu­tics’ Ukoniq (um­bral­is­ib) to treat re­lapsed or re­frac­to­ry mar­gin­al zone lym­phoma pa­tients with one pri­or an­ti-CD20 based reg­i­men and re­lapsed or re­frac­to­ry fol­lic­u­lar lym­phoma pa­tients who have re­ceived at least three pri­or lines of sys­temic ther­a­py.

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