Thursday, November 12, 2026
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On September 24, 2026, the FDA approved belzutifan with lenvatinib for adults with advanced clear-cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor; versus cabozantinib, median progression-free survival was 14.6 versus 10.6 months (HR 0.74), while the final overall survival comparison was not statistically significant (HR 0.85).
U.S. FDA
A multicenter series of 77 patients with stage I to IV renal cell carcinoma, published in JCO Oncology Advances on January 21, 2026, found that Signatera ctDNA positivity in the molecular-residual-disease window was associated with inferior recurrence-free survival in the landmark analysis (HR 18; 95% CI 4.9 to 67).
JCO Oncology Advances
A preliminary ASCO GU 2026 report from MONSTAR-SCREEN-3, with results available for 16 of 30 enrolled patients with resectable renal cell carcinoma, found baseline ctDNA in 16 of 16 evaluable patients using a tumor-informed whole-genome assay, including 9 of 16 below 100 parts per million.
Journal of Clinical Oncology
The 2026 NCCN kidney cancer discussion added a recommendation, for non-clear-cell renal cell carcinoma, to consider tumor genomic testing for clinical-trial eligibility.
The ASCO Post
On June 12, 2026, the FDA approved belzutifan with pembrolizumab, or with pembrolizumab and berahyaluronidase alfa-pmph, as adjuvant treatment for adults with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastases; in LITESPARK-022 (1,841 patients) disease-free survival HR was 0.72 and median disease-free survival was not reached in either arm.
U.S. FDA
At the NCCN 2026 Annual Conference, faculty reported that ipilimumab plus nivolumab moved from category 2A to a category 1 preferred first-line regimen for clear-cell renal cell carcinoma.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference said subsequent therapy for renal cell carcinoma now includes lenvatinib as a category 2A option in defined settings, while axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab moved from category 2A to 2B, and axitinib plus avelumab was removed.
The ASCO Post