Belzutifan and Lenvatinib Combination Gains FDA Approval for Advanced RCC

The FDA has approved belzutifan (WELIREG, Merck) in combination with lenvatinib (Lenvima, Eisai) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) who have received a PD-1 or a PD-L1 inhibitor.

This marks the third ccRCC approval for belzutifan. It has previously been approved as an adjuvant treatment with pembrolizumab and as monotherapy for advanced ccRCC after both a PD-1 or PD-L1 inhibitor and a VEGF TKI.

Lenvatinib is also indicated for advanced RCC, first line in combination with pembrolizumab and second line with everolimus following one prior anti-angiogenic therapy.