{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T20:49:06Z","timestamp":1790887746083,"version":"4.1.0"},"reference-count":8,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In February 2025, the European Commission granted approval for belzutifan (Welireg) as a treatment for certain von Hippel\u2013Lindau (VHL) disease-associated tumors. This is the first medicinal product in Europe for pharmacological management of VHL, a rare, hereditary condition characterized by the development of multiple tumors across various organs. Belzutifan is an oral inhibitor of hypoxia-inducible factor-2\u03b1 (HIF-2\u03b1), a protein involved in the pathogenesis of VHL-associated tumors. This approval, which is based on the results of the pivotal phase 2 clinical trial MK-6482-004 (LITESPARK-004) offers a therapeutic approach to managing certain VHL disease-associated tumors. This article describes the clinical data supporting belzutifan approval in the EU, focusing on the VHL disease indication and its mechanism of action.<\/jats:p>","DOI":"10.1093\/oncolo\/oyaf433","type":"journal-article","created":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T12:29:35Z","timestamp":1767702575000},"source":"Crossref","is-referenced-by-count":6,"title":["The European medicines agency review of belzutifan (Welireg) for the treatment of adult patients with von Hippel\u2013Lindau disease-associated tumors"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-5765-5713","authenticated-orcid":false,"given":"Antonella","family":"Baron","sequence":"first","affiliation":[{"name":"European Medicines Agency , Amsterdam, HS 1083,","place":["the Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Broekman","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, University Medical Centre Groningen, University of Groningen , Groningen, GZ 9713,","place":["the Netherlands"]},{"name":"Dutch Medicines Evaluation Board , Utrecht, AH 3531,","place":["the Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martijn","family":"van Gils","sequence":"additional","affiliation":[{"name":"Dutch Medicines Evaluation Board , Utrecht, AH 3531,","place":["the Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elita","family":"Poplavska","sequence":"additional","affiliation":[{"name":"European Medicines Agency , Amsterdam, HS 1083,","place":["the Netherlands"]},{"name":"Department of Applied Pharmacy, Faculty of Pharmacy and Institute of Public Health, Riga Stradi\u0146\u0161 University , Riga, LV-1007,","place":["Latvia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Mol","sequence":"additional","affiliation":[{"name":"European Medicines Agency , Amsterdam, HS 1083,","place":["the 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