China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.
Understanding von Hippel-Lindau (VHL) Syndrome
Von Hippel-Lindau (VHL) syndrome, also known as Von Hippel-Lindau disease, is a rare genetic disorder that leads to the development of multiple benign and malignant tumors throughout the body. The condition is characterized by the development of retinal angiomas, hemangioblastomas of the cerebellum and spinal cord, and RCCs.
Welireg: A Pioneering Treatment in China
Welireg is the first and only approved drug in China that inhibits hypoxia inducible factor 2 alpha (HIF2α), which is highly expressed in various types of tumors and can promote tumor cell proliferation and survival under low oxygen conditions. This approval marks a significant advancement in the treatment of VHL-related tumors in the country.
Clinical Efficacy of Welireg
Clinical studies have demonstrated Welireg’s efficacy in VHL disease-related tumor patients, with 64% of RCC patients, 91% of CNS hemangioblastoma patients, and 44% of pNET patients experiencing complete or partial tumor remission. These results highlight Welireg’s potential to improve outcomes for patients suffering from VHL disease-related tumors.-Fineline Info & Tech
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