Michael Weiss, TG Therapeutics CEO

TG Ther­a­peu­tics with­draws U2 ap­pli­ca­tion — and its com­po­nen­t's ap­provals — one week be­fore ad­comm

The biotech sec­tor moves in mys­te­ri­ous ways.

TG Ther­a­peu­tics on Fri­day vol­un­tar­i­ly with­drew its BLA and sup­ple­men­tal NDA for the blood can­cer com­bo pro­gram U2, cit­ing Phase III sur­vival da­ta that ap­peared to fa­vor the con­trol arm over the drug. It’s the same da­ta that spurred an ODAC hear­ing, one for which CEO Michael Weiss said he was “look­ing for­ward,” as well as a par­tial FDA hold.

The biotech is al­so with­draw­ing one com­po­nent of U2 — um­bral­is­ib — from its ap­proved in­di­ca­tions of two dif­fer­ent lym­phomas. The planned ad­comm, orig­i­nal­ly sched­uled for April 22 as the sec­ond day of a two-day hear­ing for the en­tire PI3K drug class, has sub­se­quent­ly been can­celed, TG Ther­a­peu­tics said.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.