The FDA approved daraxonrasib for pancreatic cancer, cleared zanidatamab-based regimens for HER2-positive gastric cancer, and more.
News|Articles|May 1, 2025
OncLive’s FDA Approval Report: The Regulatory Rundown for April 2025
Author(s)Kristi Rosa
Here is your snapshot for all therapeutic options that were cleared by the FDA in April 2025 spanning tumor types.
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Below is your guide to all the oncologic therapeutic options approved by the FDA in April 2025. The roundup provides everything you need to know, right at your fingertips—all the topline findings that supported the decisions and expert insights detailing what they mean for clinical practice.
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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.
Ivonescimab plus chemotherapy significantly improved overall survival vs durvalumab plus chemotherapy in advanced biliary tract cancer.
The FDA set a target action date of February 2027 for the dostarlimab-gxly sBLA in dMMR/MSI-H locally advanced rectal cancer.
UroGen submitted an NDA for UGN-103 in recurrent NMIBC, T-DXd improved PFS in first-line HER2-mutant lung cancer, and more.
The FDA approved camizestrant plus a CDK4/6 inhibitor for hormone receptor–positive, HER2-negative metastatic breast cancer that acquires an ESR1 mutation.
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