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Sopherion Therapeutics, Inc.

http://www.sopherion.com/

Latest From Sopherion Therapeutics, Inc.

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

US FDA Performance Tracker Approvals

PI3K Inhibitors For Hematology Indications Need Randomized Data, FDA Panel Says

Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.

Advisory Committees Drug Approval Standards

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.

Advisory Committees Drug Safety

Despite FDA Setback, MEI’s Zandelisib Could Still Break PI3K Curse

MEI/Kyowa Kirin will no longer seek accelerated approval based on a single-arm study as the FDA is calling for Phase III data due to growing conservatism regarding the PI3K class.

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