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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