Lilly's approved cancer drug Lartruvo fails confirmatory study, setting the stage for withdrawal of regulatory endorsement
Back in 2016, Lilly won FDA accelerated approval for its soft tissue drug olaratumab on the basis of encouraging data from a small 133-patient mid-stage study, but on Friday a larger, confirmatory trial meant to cement the approval showed that the treatment failed to help patients live longer, which means the US health regulator can rescind its endorsement of the drug.
The drug, sold as Lartruvo, had won the FDA nod in combination with the chemotherapy doxorubicin as a first-line treatment for a subset of patients with the disease, which had seen no new approvals in decades. By the third quarter of 2018, Lilly had raked in $221.2 million in Lartruvo sales last year.
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