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First Oral Treatment for Adrenal Tumors OK’d Free

May 14, 2025

The FDA has approved belzutifan (Welireg; Merck) for patients with locally advanced, inoperable, or metastatic pheochromocytoma or paraganglioma (together known as PPGL), rare neuroendocrine tumors that occur in the adrenal gland and outside the adrenal gland, respectively. The decision was based on results from the open-label LITESPARK-015 trial, in which 72 patients with PPGL received belzutifan monotherapy. The objective response rate was 26%, and the median duration of response was 20.4 months. Belzutifan was approved in December 2023 for renal cell carcinoma.

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