The FDA doesn’t seem to like PI3Ki, especially umbralisib.
We have already covered the voluntary withdrawal by the TG Therapeutics of its application for use in CLL of umbralisib in combination with ublituximab (U2 combination) after the FDA made it very clear that it is not likely to be approved soon, if ever.
See: TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA (biologics license application/supplemental new drug application) for U2 to Treat Patients with CLL and SLL: The End of the Road for Any New PI3Ki for CLL/SLL?
Now its approvals in marginal zone lymphoma (MZL) and follicular lymphoma (FL) are being withdrawn by the FDA.
From the FDA, see: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns. Possible increased risk of death outweighs the benefits
While we are 100% supportive of the need for safety concerns to be carefully and fully addressed and recognize that PI3Ki have a significant potential downside, we argue when used properly with careful monitoring and aggressive management of adverse events, they offer a proven benefit for CLL patients with few if any approved options.
CLL Society is fighting to find a middle ground where the admittedly few CLL patients who get significant benefit from this class of agents will still have this option to discuss with their healthcare team.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-Founder, Executive VP, and Chief Medical Officer
CLL Society, Inc.