On March 16, 2021, Merck announced that the U.S. FDA approved Welireg (belzutifan) for the treatment of adult patients with renal cell carcinoma (RCC) associated with VHL syndrome, central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) who do not require immediate surgery. Its indications have now been expanded to include the treatment of adult patients with advanced RCC whose disease has progressed despite treatment with programmed death receptor-1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitors and vascular endothelial growth factor tyrosine kinase inhibitors (VEGF-TKIs); and for the treatment of adult and pediatric patients aged 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
Adverse Reactions/Side Effects of Bezotiva
1. Lindau Syndrome: The most common (≥25%) adverse reactions include laboratory abnormalities such as decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased blood glucose, and nausea.
2. Advanced Renal Cell Carcinoma: The most common (≥25%) adverse reactions include laboratory abnormalities such as decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, lymphopenia, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.
3. VHL Disease: The most common (≥25%) adverse reactions (including laboratory abnormalities) are decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased blood glucose, and nausea.
4. PPGL: The most common (≥25%) adverse reactions (including abnormal laboratory indicators) include anemia, fatigue, musculoskeletal pain, lymphopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated calcium, dyspnea, elevated potassium, leukopenia, headache, elevated alkaline phosphatase, dizziness, and nausea.
