FDA officially pulls accelerated nod for Truseltiq in cholangiocarcinoma
Phase 3Drug ApprovalAccelerated Approval
The FDA has officially rescinded the accelerated approval granted to BridgeBio Pharma's Truseltiq (infigratinib) in 2021 for previously treated advanced cholangiocarcinoma with an FGFR2 fusion or rearrangement.
The 2021 nod was contingent upon the drug's sponsor, BridgeBio affiliate QED Therapeutics, conducting post-marketing trials to verify the clinical benefit observed in the initial single-arm study that had supported the accelerated approval.
However, according to an FDA notice dated May 16, QED cited difficulties in recruiting people for the required confirmatory study, which was testing Truseltiq in first-line cholangiocarcinoma. As a result, the sponsor determined it was "not commercially reasonable" to continue distributing the drug for its approved second-line indication.
Achondroplasia hopes remain
The FDA pulling its approval of Truseltiq isn't a surprise given that Helsinn had already decided back in late 2022 to permanently discontinue distribution of Truseltiq and to seek its withdrawal from the US market due to business reasons. LianBio, which has rights to the drug in China and some other Asian markets, said at the time that it intended to close the Phase III PROOF-301 trial that was testing Truseltiq in first-line cholangiocarcinoma.
Meanwhile, BridgeBio is evaluating the FGFR1-3 tyrosine kinase inhibitor as a potential treatment for achondroplasia and recently granted exclusive Japanese rights to Kyowa Kirin for $100 million upfront plus unspecified milestones.
Elsewhere, the FDA is expected to make a decision on BridgeBio's TTR stabiliser acoramidis in transthyretin amyloid cardiomyopathy by November 29. Bayer recently gained exclusive rights to commercialise the therapy in Europe pending approval there. BridgeBio also recently spun out its subsidiary into a new company, which launched earlier this month with $200 million to fund some early KRAS-focused cancer programmes.
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