^
    Back
    Association details:
    Biomarker:VHL mutation
    Cancer:Renal Cell Carcinoma
    Drug:Welireg (belzutifan) (HIF-2α inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Title:

    FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2a) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

    Published date:
    08/13/2021
    Excerpt:
    WELIREG is a hypoxia-inducible factor inhibitor indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    09/08/2021
    Excerpt:
    Kidney-Specific Systemic Therapy for Patients with Confirmed Hereditary RCC...For VHL, belzutifan was added as a category 2A...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma

    Excerpt:
    ...To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology irrespective of VHL gene mutation status`Number of participants who experience abnormalities observed in vital signs measurements....
    Trial ID:
    MK-6482-030