TG Therapeutics lymphatic cancer treatment Ukoniq no longer authorised by USFDA
The U.S. health regulator said based on updated clinical trial data it has determined that the risks of treatment with Ukoniq outweigh its benefits.;
New Delhi: The U.S. Food and Drug Administration said on Wednesday it has withdrawn its approval for TG Therapeutics Inc's lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients receiving the drug.
Ukoniq received accelerated approval in the United States in February last year to treat adult patients with marginal zone lymphoma who have received prior therapy and for the treatment of adult patients with follicular lymphoma.
The U.S. health regulator said based on updated clinical trial data it has determined that the risks of treatment with Ukoniq outweigh its benefits.
In April, TG Therapeutics withdrew the drug from sale in the United States amid the ongoing safety issues and pulled its application for expanded use of the drug for other types of lymphomas.
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