Overview
- The FDA on Friday approved oral belzutifan combined with pembrolizumab for adults with clear cell renal cell carcinoma who are at intermediate-high or high risk of recurrence after nephrectomy or nephrectomy plus resection of metastases.
- The approval was based on the phase III LITESPARK-022 trial that cut the risk of disease recurrence or death by 28% versus pembrolizumab plus placebo, with 24-month disease-free survival of 80.7% versus 73.7% and a hazard ratio of 0.72 (P=0.0003).
- The label specifies belzutifan 120 mg taken orally once daily with pembrolizumab 200 mg IV every three weeks or 400 mg every six weeks and recommends belzutifan for up to 54 weeks and pembrolizumab for up to 12 months or until recurrence or unacceptable toxicity.
- Safety warnings note common side effects such as fatigue, anemia and liver enzyme rises, while serious adverse events occurred in about 30% of patients on the combination including pneumonia, hypoxia and pneumonitis, and both drugs carry embryo-fetal toxicity warnings.
- Overall survival data remain immature with roughly 30% of events accrued, so regulators will track longer-term survival and real-world safety and clinicians should monitor patients closely for blood, respiratory and liver toxicities.