Lartruvo was granted accelerated approval by the FDA in 2016 to treat soft tissue sarcoma after promising results from an early stage study. At that time, the company had to complete a larger trial to confirm its results.
Last week, Eli Lilly said that the late-stage study didn’t show that the drug improved survival in patients with advanced or metastatic cancer.
“In light of this information, the FDA recommends that patients who are currently receiving Lartruvo should consult with their healthcare provider about whether to remain on the treatment,” the agency said. “The FDA also recommends that Lartruvo should not be initiated in new patients outside of an investigational study.”
Eli Lilly has suspended promotion of the drug and said the study results don’t support starting the treatment.
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