Other safety alerts
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| The United States: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns |
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The US Food and Drug Administration (FDA) announces that, due to safety concerns, FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, FDA determined the risks of treatment with Ukoniq outweigh its benefits. Based upon this determination, the drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in MZL and FL.
Health care professionals should stop prescribing Ukoniq and switch patients to alternative treatments. Inform patients currently taking Ukoniq of the increased risk of death seen in the clinical trial and advise them to stop taking the medicine. In limited circumstances in which a patient may be receiving benefit from Ukoniq, TG Therapeutics plans to make it available under expanded access. Patients should talk to their health care professionals about alternative treatments and stop taking Ukoniq.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-approval-lymphoma-medicine-ukoniq-umbralisib-withdrawn-due-safety-concerns
In Hong Kong, there is no registered pharmaceutical product containing umbralisib. Related news was previously issued by FDA, and was posted on the Drug Office website on 4 Feb 2022.
Ends/Thursday, Jun 2, 2022
Issued at HKT 15:00
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