Eric Jonasch, MD, principal investigator of Study 004 and professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center speaks about FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors.
WELIREG is the first HIF-2 inhibitor treatment to receive FDA approval in the United States. WELIREG inhibits transcription and expression of HIF-2 target genes linked with cellular proliferation, angiogenesis, and tumor development as an HIF-2 inhibitor.
A boxed warning on the WELIREG label states that exposure to WELIREG during pregnancy might cause embryo-fetal damage. Before starting WELIREG, be sure you’re not pregnant. Inform patients on the dangers and the need of using effective non-hormonal contraception. Some hormonal contraceptives may be rendered ineffective by WELIREG. WELIREG can lead to severe anemia, which may necessitate a blood transfusion. Before starting WELIREG, and at regular intervals during therapy, check for anemia. WELIREG can induce severe hypoxia, which may necessitate stopping the medication, using supplementary oxygen, or being admitted to the hospital. Before starting WELIREG therapy and at regular intervals during it, check your oxygen saturation. See “Selected Safety Information” below for further information.
Merck is trying to optimize WELIREG manufacturing in order to provide a long-term supply to satisfy expected demand in the United States. By early September, commercial supplies should be accessible.
The approval was based on data from Study 004 ( ClinicalTrials.gov, NCT03401788)
https://clinicaltrials.gov/ct2/show/NCT03401788