FDA Has Been Investigating Ukoniq for an Increased Risk of Death in Lymphoma Cancer Patients Treated With Ukoniq

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In early February 2022 we learned this Drug Safety Communication, “FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)“, we learned about a so-called “safety signal” for Ukoniq that got the attention of the FDA. 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“.  This earlier Drug Injury Watch article included the mention of an Ukoniq FDA Advisory Committee meeting for evaluating this new Ukoniq drug safety issue.

From a February 3, 2022, MedPage Today piece, “FDA Concerned About Safety of Lymphoma Drug“, in relevant part:

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.

Now we know that this Ukoniq FDA Advisory Committee meeting will be convened in April 2022. From this March 10, 2022 press release item, “TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting“, we get these details:

[T]he U.S. Food and Drug Administration (FDA) has set a date of April 22, 2022 for the previously announced meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)….

The FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed. The FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.

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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