Lilly's Lartruvo Scores Broad FDA Approval In Orphan Sarcomas
Accelerated filing was supported by trial of patients with 25 subtypes of soft tissue sarcoma and confirmatory study will span 50 kinds.
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Delegates at this year’s ASCO meeting in Chicago will hear late-breaking clinical data for a number of studies from AstraZeneca, Novartis, Pfizer, Astellas, Merck & Co and Seattle Genetics which are set to shake up their respective markets. There will also be more clarity on where Lilly’s Lartruvo went so wrong.
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.