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)
Copyright (c) 2025 Dow Jones & Company, Inc.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。