FDA Yanks Next Gen Tx from the Market – Ukoniq

Now here’s something ya don’t see every day!
A drug approved within the last year being yanked from the market.

This week, the FDA pulled approval for Ukoniq directly related to safety concerns. Earlier this year, the FDA started its investigation when post launch clinical data showed possible increased risk of death from taking Ukoniq.

In February of 2021, Ukoniq, a PI3K / CK1 inhibitor, was granted accelerated approval for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL).

However, PI3K inhibitors started to display clinical concerns resulting in an FDA advisory committee recommendation that halted single-arm clinical studies of PI3K inhibitors to document safety concerns. Further, the FDA’s Oncologic Drug Advisory Committee recommended the use of randomized clinical trials. And the FDA ‘net’ is now expanding with reviews of P13K therapies in general.

One other aspect of this story should also be considered, that being the Accelerated Approval program itself. The number of drugs approved under accelerated approval has mushroomed in recent years….. that was laudable through helping drugs of value reach the marketplace sooner….. until something goes terribly wrong. The boosters quickly become nay-sayers….. especially when deaths are involved….. and the FDA itself is under the microscope for its efficiencies or lack thereof.

from MedWatch

FDA Approval of Lymphoma Medicine Ukoniq (umbralisib) is Withdrawn Due to Safety Concerns

AUDIENCE: Oncology, Patient, Health Professional, Pharmacy

ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).

Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, the 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 marginal zone lymphoma and follicular lymphoma.

BACKGROUND: Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma and follicular lymphoma.

RECOMMENDATIONS: 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 your health care professionals about alternative treatments and stop taking Ukoniq.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


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