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FDA withdraws approval for TG Therapeutics cancer treatment -Breaking

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© Reuters. FILE PHOTO – Signage outside the Food and Drug Administration headquarters in White Oak (Maryland, U.S.A), August 29, 2020. REUTERS/Andrew Kelly/File Photograph

(Reuters) – The U.S. Food and Drug Administration (NASDAQ:) Inc has withdrawn approval for TG Therapeutics’ lymphatic cancer treatment Ukoniq due to concerns about a higher death rate in patients who receive the drug.

Ukoniq was approved in the United States for treatment of adults with marginal lymphoma after they have had prior treatments. It also received expedited approval to be used in treating adult patients suffering from follicular lymphoma.

Although the U.S. regulator of health has not often withdrawn treatment approvals, it has done so recently for drug approved through its “accelerated approval” process.

This pathway is used for patients with rare conditions or those who have not had effective treatment. FDA used it to approve Biogen Inc’s controversial Alzheimer’s Disease drug last year despite concerns about efficacy.

According to the U.S. regulator of health, Ukoniq has outweighed its potential benefits based upon updated data from clinical trials.

TG Therapeutics, a company that manufactures the drug in the United States, withdrew it from sale due to ongoing safety concerns and pulled its application for extended use for lymphomas.

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