FDA Withdraws Approval for Umbralisib (Ukoniq) Due to Safety Concerns
The FDA released a Drug Safety Communication on June 1, 20221 withdrawing 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). Ukoniq (umbralisib) is a PI3 kinase inhibitor approved by the FDA in February 2021 for the treatment of marginal zone lymphoma (MZL) with at lest one prior anti-CD20-based regimen and follicular lymphoma (FL) with at least three prior lines of systemic therapy.
The FDA released a Drug Safety Communication on February 3, 2022,2 warning of possible increased risk of death with umbralisib (Ukoniq) used for the treatment of lymphoma. Updated clinical trial findings continued to show a possible increased risk of death in patients receiving Ukoniq (umbralisib). The FDA determined that the risks of treatment with Ukoniq (umbralisib) outweigh its benefits. The drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq (umbralisib) from the market for the approved uses in MZL and FL.3
Recommendations for Health Care Providers
- Stop prescribing Ukoniq (umbralisib) and switch patients to alternative treatments.
- Inform patients currently taking Ukoniq (umbralisib) 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 (umbralisib), TG Therapeutics plans to make it available under expanded access .
- Encourage patients to take unused Ukoniq (umbralisib) to drug take back locations. If drug take back locations are not available
advise them to safely dispose of unused Ukoniq (umbralisib) in their household trash by doing the following:
- Mix the medicine with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away the container in your home trash.
- Delete all personal information on the prescription labels of empty medicine bottles or packaging, then throw away or recycle
To help the FDA track safety issues with Ukoniq (umbralisib) or other medications, please report adverse events to the MedWatch program as recommended in the Indian Health Manual. Instructions for reporting can be found online at the NPTC Pharmacovigilance website.
1. Food and Drug Administration. (2022, June 1). FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns.
2. Food and Drug Administration. (2022, February 3). FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib).
3. TG Therapeutics. (April 15, 2022). TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL.