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TG Therapeutics Ukoniq’s Future In Doubt Amidst Scrutiny Of P13K Inhibitor Accelerated Approvals

 
• By Bridget Silverman

Advisory committee review of combo with ublituximab may provide forum to discuss the Phase III data showing increased risk of death that prompted US FDA safety alert.

GREEN BLURRY BUBBLES
The risk profile of the leukemia and lymphoma therapies are blurry after FDA's drug safety communication. • Source: Alamy

TG Therapeutics, Inc.’s Ukoniq (umbralisib) is the latest drug to stumble over the safety issues that have long plagued the phosphatidylinositol 3-kinase (PI3K) inhibitor class. The small group of leukemia and lymphoma therapies are getting a new level of regulatory attention as the US FDA builds out from its 2021 crackdown on “dangling” and “delinquent” accelerated approvals in oncology.

The FDA is “investigating a possible increased risk of death” with Ukoniq, according to a drug safety communication issued on 3 February 2022 – almost exactly one year after the PI3K delta and casein kinase 1 (CK1) epsilon inhibitor’s accelerated approval on 5 February 2021 for two indications: relapsed or refractory marginal zone lymphoma (MZL) patients who received at least one prior

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UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

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