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17-08-2021 | FDA | News

approvalsWatch

FDA approves HIF-2α inhibitor belzutifan for VHL-associated tumors

Author:
Hannah Kitt

medwireNews: The US FDA has approved the use of belzutifan (previously MK-6482) in patients with von Hippel–Lindau (VHL) disease who require therapy for associated tumors.

Specifically, the hypoxia-inducible factor-2α inhibitor may now be given to adults with VHL-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNETs) that do not need immediate surgery.

The decision is based on the results of Study 004, which demonstrated an overall response rate of 49% in the RCC group, and of 63% and 83% in the CNS hemangioblastoma and pNET groups, respectively. The median duration of response was unreached in all groups.

The recommended dose of belzutifan is 120 mg given orally once a day and the agent carries a boxed warning specifying that it can render some hormonal contraceptives ineffective, while its use during pregnancy may cause embryo–fetal harm. Physicians are therefore advised to verify pregnancy status prior to treatment initiation and inform patients about the treatment-associated risks and the need for effective nonhormonal contraception.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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