Belzutifan: Advanced Cancer Therapy with Promising Potential

On August 13, 2021, the Food and Drug Administration (FDA) granted approval for Belzutifan, marketed under the brand name Welireg, a groundbreaking hypoxia-inducible factor inhibitor. This approval is a significant milestone for adult patients diagnosed with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not necessitating immediate surgery. Belzutifan’s effectiveness was established through an ongoing clinical trial involving patients with von Hippel-Lindau-associated tumors, demonstrating remarkable results and a potential game-changer in the field of oncology.

Project Orbis

The FDA’s approval of Belzutifan was conducted under Project Orbis, an initiative aimed at facilitating the concurrent submission and review of oncology drugs among international partners. This collaborative approach allows for an accelerated review process and expedites the availability of groundbreaking treatments to patients worldwide.

Efficacy in Von Hippel-Lindau-Associated Renal Cell Carcinoma

In the clinical trial, Belzutifan demonstrated impressive efficacy in patients with von Hippel-Lindau-associated renal cell carcinoma. A remarkable 49% overall response rate was reported, as measured by a radiology assessment conducted by an independent review committee using RECIST v1.1 criteria. The median duration of response was not reached, with 56% of responders experiencing response durations lasting more than 12 months. The median time-to-response was 8 months, showcasing Belzutifan’s effectiveness in this patient group.

Dosage and Administration

Welireg is ideally administered at a daily dosage of 120mg, taken orally with or without food. The medication is available in tablet form, with each tablet containing 40mg of the active ingredient. This dosing regimen offers flexibility to patients while ensuring the effective use of Welireg in the treatment of von Hippel-Lindau disease-associated conditions, including renal cell carcinoma, central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors.

Warning and Precaution

Welireg tablet requires vigilant monitoring for anemia and hypoxia. Anemia necessitates withholding the medication until hemoglobin levels reach ≥9g/dL, followed by consideration for resumed use at a reduced dose or discontinuation, especially in cases of life-threatening anemia. Hypoxia at rest warrants temporary suspension, followed by a decision to resume at a reduced dose or discontinue, with life-threatening hypoxia necessitating permanent discontinuation. In specific populations, Welireg tablet may impact fertility in both males and females, and breastfeeding is not advised due to potential risks to the infant.

Safety and Adverse Reactions

Belzutifan’s effectiveness is notable, but its safety profile is essential to consider. Common adverse reactions in over 20% of patients included decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea. Anemia and severe hypoxia were experienced by many patients, with 90% having anemia and 7% having grade 3 anemia. Hypoxia affected 1.6% of patients, and using erythropoiesis-stimulating agents for anemia is not recommended with Belzutifan. It can also affect the effectiveness of some hormonal contraceptives, and pregnancy exposure can harm the embryo-fetus.

Conclusion

The FDA’s approval of Belzutifan represents a significant step forward in the treatment of von Hippel-Lindau disease. With remarkable efficacy demonstrated in patients with renal cell carcinoma, central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors, Belzutifan offers new hope to those with limited treatment options. However, its safety profile highlights the need for close monitoring and management of adverse reactions. Belzutifan’s approval through Project Orbis underscores the importance of international collaboration in advancing oncology treatments, benefiting patients across the globe. Welireg price in India depends on the product requirement. Request more details by contacting our Patient Support Team at ‎(+91) 93157 05373 or help@sansfro.com. 

References: 

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9551368/
3. https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.2008