FDA Probing Possible Death Risk Of Lymphoma Drug

U.S. federal drug regulators are looking into whether a TG Therapeutics lymphoma treatment might increase a risk of its users dying.

The U.S. Food and Drug Administration said in a Feb. 3 announcement that it would start an investigation into “a possible increased risk of death with the cancer medicine Ukoniq … approved to treat two specific types of lymphomas.”

The FDA said it is “continuing to evaluate the results from the clinical trial.”

“FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq,” the agency said.

The FDA about a year ago gave Ukoniq the accelerated green light, noting at the time that the treatment was meant for certain adult patients with certain types of lymphoma.

At the time of approval, TG Therapeutics said its Ukoniq brand was “the first and only” product of its type.

The government said in its latest announcement that it was putting off allowing new patients to take part in clinical trials relating to the treatment.

LAW360: https://www.law360.com/articles/1462141/fda-probing-possible-death-risk-of-lymphoma-drug

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