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TG Therapeutics Pulls Ukoniq/Ublitiximab Combo Applications Due To Adverse Survival Trend

 
• By Sue Sutter

Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.

Shovel in dirt
FDA has 'dug in' on the adverse survival trends seen with PI3K inhibitors, TG Therapeutics says. • Source: Alamy

Safety issues have felled another member of the phosphatidylinositol 3-kinase (PI3K) inhibitor class, TG Therapeutics, Inc.’s lymphoma drug Ukoniq (umbralisib), and with it combination use with a new anti-CD20 monoclonal antibody, ublituximab, in oncology indications.

On 15 April, TG Therapeutics announced it had withdrawn the pending US applications for the combination of ublituximab and umbralisib (“U2”) for the treatment of adults with chronic

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