FDA Oncologic Drugs Advisory Committee Meeting in Near Future May Consider Possible Ukoniq Drug Recall
We learned in early February 2022 about an FDA investigation of Ukoniq (umbralisib) after a so-called "safety signal" indicated an association between Ukoniq and increased risk of death in patients treated with Ukoniq for their lymphoma cancer. Ukoniq was approved by the FDA in February 2021 to treat adults with two types of lymphoma:
- Marginal Zone Lymphoma (MZL), when this type of lymphoma cancer has returned or it did not respond to prior treatment with at least one specific type of medicine; and,
- Follicular Lymphoma (FL), when this type of lymphoma cancer has returned or it did not respond to at least three prior treatments.
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)".
In particular, from that February 2022 Ukoniq FDA Drug Safety Communication we get these two points:
- We conducted an initial review of data from UNITY, a phase 3, randomized, controlled clinical trial in patients with chronic lymphocytic leukemia (CLL). The trial is evaluating Ukoniq in combination with a monoclonal antibody drug that targets a specific protein called CD20 compared to the control arm in which patients received standard treatment. The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm.... The UNITY trial was conducted in CLL patients, which is not an approved use but rather a use of this drug that is being studied; however, we believe these findings have implications for its approved uses for MZL and FL.
- We are continuing to evaluate the results from the clinical trial called UNITY. FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq. We have also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while we continue to review the UNITY findings. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.
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.
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For more on this aspect of the new FDA investigation of Ukoniq, we turn to an article, "FDA Concerned About Safety of Lymphoma Drug", by medical reporter Charles Bankhead, which was published on February 3, 2022, by MedPage Today:
The potential adverse safety signal arose from the phase III UNITY-CLL trial comparing [Ukoniq (umbralisib)] plus the anti-CD20 antibody ublituximab versus obinutuzumab (Gazyva) plus chlorambucil for chronic lymphocytic leukemia [(CLL)]. [Ukoniq (umbralisib)] currently has approved indications for relapsed/refractory marginal zone lymphoma [(MZL)] and follicular lymphoma [(FL)]....
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 this Ukoniq safety signal and watch for any related FDA regulatory action, including a possible Ukoniq drug recall in the future. Any significant developments related to this new drug safety issue of Ukoniq and increased risk of death will be reported promptly here on Drug Injury Watch.
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