TG Therapeutics Pulls Ukoniq/Ublitiximab Combo Applications Due To Adverse Survival Trend
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.
You may also be interested in...
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker