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.
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