By Kelly Cloonan
Merck has received approval from the Food and Drug Administration for Welireg, its oral inhibitor for patients with certain rare types of neuroendocrine tumors.
The company said Wednesday the treatment is for locally advanced unresectable, or metastatic pheochromocytoma or paraganglioma, which are caused by certain genetic syndromes or mutations.
The approval makes Welireg the only approved and available treatment in the U.S. for eligible patients with advanced PPGL, the company said.
"For patients with advanced PPGL, there has been a lack of approved systemic treatment options available to help manage their disease," said Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories.
The approval is based on data from the company's Phase 2 clinical trial, where the primary endpoint was objective response rate, the company said.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
May 14, 2025 17:55 ET (21:55 GMT)
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