- The FDA withdrew its approval for TG Therapeutics Inc.’s lymphatic cancer treatment.
- This, due to concerns about an increased risk of death in patients receiving the drug.
- Ukoniq received accelerated approval in the United States in February of last year to treat adult patients with marginal zone lymphoma.
The Food and Drug Administration (FDA) of the US said on Wednesday that it withdrew its approval for the lymphatic cancer treatment of TG Therapeutics Inc (TGTX.O) Ukoniq over concerns about an increased risk of death in patients receiving the drug.
Ukoniq received accelerated approval in the United States in February of last year.
Ukoniq received accelerated approval in the United States in February of last year. to treat adult patients with marginal zone lymphoma who had received prior therapy and for the treatment of adult patients with follicular lymphoma.
The US health regulator has rarely withdrawn approval of treatments, but has recently done so for drugs approved under its “accelerated approval” pathway.
The pathway, primarily for rare diseases or small populations of patients who have not had effective treatments, has come under increasing scrutiny after the FDA used it last year to approve Biogen’s controversial Alzheimer’s drug. Inc. (BIIB.O) despite concerns about its effectiveness.
In April, TG Therapeutics withdrew the drug from sale in the United States due to ongoing safety concerns.
The US health regulator said that, based on updated clinical trial datas, determined that the risks of treatment with Ukoniq outweigh its benefits.
The FDA said that, based on updated data from clinical trials, it has determined that the risks of treatment with Ukoniq outweigh its benefits.
In April, TG Therapeutics withdrew the drug from the sale in the United States due to ongoing safety concerns and withdrew its request to expand the use of the drug for other types of lymphomas.
TG Therapeutics withdrew the drug from sale in the United States amid ongoing safety concerns and withdrew its request to expand the use of the drug for other types of lymphomas.
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