UroGen submitted an NDA for UGN-103 in recurrent NMIBC, T-DXd improved PFS in first-line HER2-mutant lung cancer, and more.
News|Articles|May 30, 2025
OncLive’s FDA Approval Report: The Regulatory Rundown for May 2025
Author(s)OncLive Staff
Fact checked by: Kristi Rosa
Here is your snapshot of all therapeutic options that were approved by the FDA in May 2025 spanning tumor types.
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Below is your guide to all the oncologic therapeutic options cleared by the FDA in May 2025. The roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights contextualizing what they mean for clinical practice.
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Daraxonrasib produced a 42% overall response rate and 16.0-month median OS in previously treated RAS-mutant NSCLC in a phase 1/2 trial.
Ivonescimab significantly improved OS vs pembrolizumab at a prespecified interim analysis of the HARMONi-2 trial in first-line PD-L1–positive NSCLC.
A pharmacokinetic sub-study found that TAMP-mediated gemcitabine reduced systemic drug exposure in patients with locally advanced pancreatic cancer.
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