The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.
The regulatory path to approval for RP1 plus nivolumab in anti–PD-1–pretreated melanoma ran through 3 BLAs, 2 CRLs, and a divided advisory committee vote.