BIO 2019 Notebook: Lartruvo Lookback, M&A Soars, BIO Vs. ASCO
News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.
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Former US FDA Commissioner Scott Gottlieb said that despite the $500m Lilly took in from sales of Lartruvo, the company probably lost money with the costs of R&D and withdrawing the drug from the market.
The presentation of the ANNOUNCE results, the failed confirmatory trial for Lilly’s Lartruvo, at ASCO re-opened questions about the accelerated approval and the appropriate way to study soft tissue sarcoma.
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.