The FDA approved lirafugratinib in FGFR2+ cholangiocarcinoma and belzutifan plus lenvatinib in advanced ccRCC, and more.
News|Articles|April 2, 2025
OncLive’s FDA Approval Report: The Regulatory Rundown for March 2025
Author(s)Kristi Rosa
Here is your snapshot for all therapeutic options that were approved by the FDA in March 2025 spanning tumor types.
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Below is your guide to all the oncologic therapeutic options cleared by the FDA in March 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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FDA grants priority review to durvalumab plus enfortumab vedotin for cisplatin-ineligible MIBC based on positive phase 3 VOLGA data.
Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.
The FDA granted final approval to Lutetium Lu 177 dotatate biosimilar for patients with SSTR-positive GEP-NETs.
The CHMP recommended perioperative pembrolizumab plus enfortumab vedotin for resectable muscle-invasive bladder cancer.
Results from an early-stage clinical trial found encouraging outcomes in newly diagnosed pancreatic cancer that had spread to distant organs.
Read a refresh of GI cancer FDA news from August 2026, including the approval of a RAS(ON) inhibitor in metastatic pancreatic cancer.
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