The longest taking time and long-term medication safety instructions for Bestivan (Vilire)

Belzutifan (trade name: Welireg) is an oral HIF-2α inhibitor, mainly used to treat von Hippel-Lindau (VHL) syndrome-related clear cell renal cell carcinoma (ccRCC), central nervous system hemangioblastoma (CNS hemangioblastomas) and pancreatic neuroendocrine tumors (pNET). The drug was approved by the US FDA in 2021, becoming the first targeted drug approved for VHL-related tumors. In 2025, bezutivan was also approved in Europe. In the Chinese market, besotivan has not yet been approved for marketing, and patients must obtain it through imported channels.

As for the long-term safety of bestifan, the existing clinical data mainly come from studies on VHL patients. In a 35-month follow-up study, 92% of 25 patients< span>Adverse reactions of any grade occurred, among which anemia was the most common, with an incidence rate of 64%, but there were no cases of anemia above Grade 3. Treatment interruptions occurred in 80% of patients and required dose reduction in 60% of patients, with a median final dose of 80 mg. Nonetheless, 89% of patients with clear cell renal cell carcinoma, 80% of patients with central nervous system hemangioblastoma, and 80% of patients with pancreatic neuroendocrine tumors experienced tumor shrinkage, demonstrating good efficacy.

Additionally, in a multicenter, open-label Phase III clinical trial, bezutivan demonstrated durable efficacy in the treatment of VHL-associated clear cell renal cell carcinoma. During a median follow-up of 21.8 months, 49% of patients achieved objective response. These data further support the role of bezotivan inSafety and efficacy for long-term use in patients with VHL.

In summary, besotivan has shown acceptable safety and good efficacy in long-term use in VHL related tumors. However, patients should be under the guidance of a professional doctor during use to ensure the safety and effectiveness of the medication. For areas where marketing approval has not yet been obtained, patients should pay attention to changes in relevant policies and choose an appropriate treatment plan with the advice of their doctor.

Reference materials:https://www.drugs.com/