We first learned from this March 10, 2022 press release item, “TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting”, that the Ukoniq FDA Advisory Committee meeting will be held on April 22, 2022. This development relates back to a Drug Safety Communication, “FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)”, issued in early February 2022. Therein, a so-called “safety signal” for Ukoniq was identified by the FDA. There were news reports back in February that mentioned there would likely be an Ukoniq FDA Advisory Committee meeting for evaluating this new Ukoniq drug safety issue.
For more on this recent Ukoniq drug safety issue, we refer you to our February 4, 2022 article, “Ukoniq Lymphoma Drug Safety Investigation Started In February 2022 to Examine Increased Risk of Death“.
To learn more about this Ukoniq FDA Advisory Committee meeting, including the availability of background material prior to the meeting and a link to the online teleconference meeting room, see April 21-22, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement.
We will continue to monitor this Ukoniq drug safety issue involving an increased risk of death, and report on any drug regulatory actions that might come after the upcoming April 2022 Ukoniq FDA Advisory Committee meeting.[Read article in full at original source]
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