TG Therapeutics suspends cancer drug research and withdraws approved cancer drug Ukoniq from the market. The move comes as the FDA conducts a thorough review of Ukoniq's drug class, concerns that will be discussed at an FDA advisory committee meeting scheduled for April 21.
Last year, TG Therapeutics applauded the regulatory approval and commercial launch of its first drug, a treatment for advanced cases of a type of lymphoma. The biotechnology aimed to expand the use of this drug, Ukoniq, as part of a combination treatment for another type of cancer. TG was preparing to make the case for the drug combination at an FDA advisory group meeting this week.
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Instead, the company is withdrawing this drug application and also removing the approved drug, Ukoniq, from the market while suspending all of its cancer programs. The move was unintentionally prophetic. Shortly after New York-based TG announced its change in strategy last Friday, The Lancet published an article written by FDA officials explaining the agency's safety concerns about the broader class of drugs. to which Ukoniq belongs. Rather than defending Ukoniq before an FDA advisory panel, TG CEO Michael Weiss is defending his company's decision to retire from cancer.
"At the time we filed the recall, we had no idea that the Lancet article would literally be published hours later," Weiss said during a conference call on Monday. “But I can assure you that the FDA is quite confident in its position. They wrote it down on a piece of paper. Anyone can read it. There is no doubt that we made the right decision. We made a commitment to the FDA and shareholders that if we saw anything that did not meet our expectations, we would not proceed."
Ukoniq belongs to a class of drugs that block phosphatidylinositol-3-kinases (PI3K), which are enzymes involved in cell proliferation. Dysregulated PI3K signaling can lead to blood cancers. By blocking these enzymes, these drugs aim to stop the cell growth that occurs in blood cancers. The FDA granted accelerated approval to Ukoniq in February 2021 for the treatment of marginal zone lymphoma. This decision was based on Phase 2 data from two single-arm groups; the main objective was to assess the overall response rate.
TG was looking to expand the use of Ukoniq to chronic lymphocytic leukemia by combining the small molecule with an experimental antibody from its pipeline, ublituximab. As part of the FDA review, the regulator asked for preliminary data on overall survival — how long patients treated with the drug lived. This review revealed an imbalance in these data that favored the control arm, TG announced last November. According to the company, these unbalanced results were not statistically significant. However, the FDA called an advisory committee meeting to discuss the drug combination further.