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.

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Ukoniq (umbralisib) was approved by the FDA in February 2021 to treat adults with two types of lymphoma cancer that have returned or it did not respond to prior treatment: Marginal Zone Lymphoma (MZL); and, Follicular Lymphoma (FL). Only a year later, however, there is a new FDA Ukoniq safety investigation after a so-called “safety signal” indicated an increased risk of death with Ukoniq that may lead to an Ukoniq drug recall.

For more detailed information about this Ukoniq safety signal, we refer you to this February 3, 2022, Drug Safety Communication, “FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)”. As seen in that second point, there may be an FDA Advisory Committee meeting to consider a possible Ukoniq drug recall in the near future.

For more on the new FDA Ukoniq safety investigation and this possible Ukoniq drug recall, we turn to an article, “FDA Concerned About Safety of Lymphoma Drug”, by medical reported Charles Bankhead, which was published on February 3, 2022, by MedPage Today:

The FDA Oncologic Drugs Advisory Committee (ODAC) may also convene to consider the findings of the safety evaluation and “explore” the continued marketing of [Ukoniq (umbralisib)]….

Late last year, [Ukoniq (umbralisib)] sponsor TG Therapeutics issued a statement acknowledging that the FDA plans to convene ODAC to consider the UNITY-CLL data within the context of the ongoing review of the company’s application for approval of the [Ukoniq (umbralisib)]/ublituximab(U2) combination….

Although ODAC has yet to announce a date for the [Ukoniq (umbralisib)] review, the FDA indicated that the meeting would occur in March or April, according to TG Therapeutics.

We will continue to monitor the FDA Ukoniq safety investigation and watch for any related FDA regulatory action, including a possible Ukoniq drug recall in the future.

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