Merck announced on January 27, 2025, that its application seeking expanded use of its Welireg oral cancer drug received U.S. Food and Drug Administration (FDA) priority review. The application is for patients with rare tumors that form in and around the adrenal glands.
The priority review designation covers Welireg for patients aged 12 years and older with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma. The FDA has set a target action date of May 26 for its decision.
If approved, Welireg would be the only available therapy in the U.S. for eligible patients with these advanced adrenal gland tumors. This expedited review highlights the significant unmet medical need and the potential of Welireg to address it, further boosting Merck's oncology portfolio.
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