Eli Lilly and Co.’s cancer drug Lartruvo shouldn’t be started in new patients, and those patients already taking it should ask their doctors if they should continue, U.S. regulators said, following a key study that failed to show the medicine prolonged lives.
The drug for soft tissue sarcoma, a relatively rare and hard-to-treat type of tumor, was given accelerated approval by the U.S. Food and Drug Administration in 2016 based on promising data from an early-stage study. The company was required to complete a larger trial to confirm the benefits. Lilly announced last week that the late-stage study didn’t meet its main goal of showing the drug improved survival in patients with advanced or metastatic disease.
“In light of this information, the FDA recommends that patients who are currently receiving Lartruvo should consult with their health care provider about whether to remain on the treatment,” the agency said in a statement. “The FDA also recommends that Lartruvo should not be initiated in new patients outside of an investigational study.”
The European Medicines Agency took a similar step Wednesday, saying no new patients should start treatment until the full results of the study, known as Announce, were made available.
The FDA and Lilly are working together to determine what steps they should take next. The company, based in Indianapolis, has suspended any promotion of the drug and said the study results don’t support starting treatment with it.