Posted by Michael Wonder on 30 Mar 2026
Elevar Therapeutics announces FDA acceptance for review of new drug application for lirafugratinib as second-line cholangiocarcinoma treatment
30 March 2026 - Elevar Therapeutics today announced that the US FDA has completed its filing review of the new drug application for lirafugratinib, an investigational therapy, for the treatment of patients with cholangiocarcinoma with FGFR2 fusions or rearrangements who have received prior therapy.
The FDA determined that the new drug application is sufficiently complete to permit a substantive review and granted priority review, with a PDUFA target action date of 27 September 2026.
