A Successful Failure? Lartruvo’s Speedy Withdrawal Sets New Bar For Accelerated Approval Drugs
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.
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Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.
News and views from day four of the BIO International Convention: emerging company M&A deals nearly double in 2018; former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; and the ASCO effect on the 3-6 June BIO meeting.