No New Patients For Lartruvo In EU After Trial Failure
Executive SummaryThe EMA says that in light of the disappointing results of the ANNOUNCE trial, no new treatments should be initiated with Lilly’s Lartruvo in patients with soft tissue sarcoma. This is the first time the agency has taken action such as this on a product that has received a conditional marketing authorization.
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News that the soft tissue sarcoma drug will come off the market after its confirmatory trial failed to verify clinical benefit spurs Memorial Sloan-Kettering’s Peter Bach to ask whether Lilly will refund money to payers.
Lilly withdraws soft tissue sarcoma drug for failure to confirm clinical benefit two and a half years after US FDA awarded accelerated approval, becoming the fastest withdrawal yet under the regulatory pathway.