The world's first PI3Kδ/CK1ε inhibitor failed due to safety concerns

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The world’s first PI3Kδ/CK1ε inhibitor failed due to safety concerns

The world’s first PI3Kδ/CK1ε inhibitor failed due to safety concerns.

The world’s first PI3Kδ/CK1ε inhibitor failed! FDA withdraws accelerated approval for Ukoniq over safety concerns.

According to the latest news, the U.S. Food and Drug Administration (FDA) has announced that it has decided to cancel the treatment approval of TG Therapeutics’ oncology drug Ukoniq (umbralisib) because the therapy may lead to an increase in patient mortality.

Affected by the bad news, TG Therapeutics shares fell rapidly on Wednesday.

The world's first PI3Kδ/CK1ε inhibitor failed due to safety concerns

On June 1, local time, U.S. regulators said that the U.S. Food and Drug Administration (FDA) finally decided to cancel the indication approval of Ukoniq as the U.S. government has been investigating the ongoing safety issues of the therapy.

In February, the U.S. Food and Drug Administration launched a safety investigation after evaluating clinical data on Ukoniq in related types of cancer, which showed that “taking the drug may lead to an increased risk of death in patients.”

Specifically, the FDA said that the results of the UNITY-CLL clinical trial of Ukoniq therapy showed that patients receiving the combination of Ukoniq and monoclonal antibodies may have an increased risk of death compared with the control group.

At the same time, the FDA also pointed out that compared with the control group, patients receiving the Ukoniq combination also experienced more serious adverse events.

Back in February 2021, Ukoniq was granted accelerated approval by the U.S. FDA to treat two different types of lymphoma.

The therapy is approved for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen and is also approved for the treatment of relapsed or refractory follicles who have received at least three prior therapies Systemic treatment of adult patients with lymphoma.

Ukoniq is the first and only approved once-daily oral phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 (CK1) epsilon inhibitor.

The FDA said in a brief statement that the agency must investigate further before it can determine that the benefits of treatment with Ukoniq outweigh the risks.

Following the withdrawal of Ukoniq’s approval for the indication, the U.S. Food and Drug Administration said health care officials in the U.S. should immediately stop prescribing Ukoniq and switch existing patients to alternative treatments.

In addition, the FDA also emphasized that health care workers should inform those patients already taking Ukoniq about the possible safety issues and advise them to stop taking the drug immediately.

It’s worth noting that Ukoniq isn’t the only P13K inhibitor with safety concerns. Previously, Gilead has also removed its P13K inhibitor Zydelig (idelalisib) from the market.

At present, the safety of PI3K inhibitors has become a class of drugs that the US FDA is extremely concerned about.

Earlier this year, the FDA advisory committee voted overwhelmingly to recommend stopping single-arm clinical studies of PI3K inhibitors due to safety concerns.

In addition, the FDA’s Oncology Drugs Advisory Committee recommended the use of randomized clinical trials to mitigate safety concerns with PI3K inhibitors.

Reference:

FDA Pulls Approval for TG Therapeutics’ Cancer Drug

The world’s first PI3Kδ/CK1ε inhibitor failed due to safety concerns

(source:internet, reference only)

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