FDA Approves Welireg for Advanced Kidney Cancer Subtype

The Food and Drug Administration (FDA) has approved Welireg (beluztifan) for patients with advanced renal cell carcinoma (RCC) following treatment with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

The approval was based on findings from the LITESPARK-005 trial, which included 746 patients with unresectable locally advanced or metastatic clear cell RCC that had progressed after both a PD-1 or PD-L1 checkpoint inhibitor, and a VEGF-TKI, the agency announced.

Learn More: Welireg Outperforms Afinitor in Advanced Clear Cell Kidney Cancer

Trial findings presented earlier this year at the European Society of Medical Oncology Annual Congress (ESMO) showed that at a median follow-up of 18.4 months, patients treated with Welireg experienced objective response rates (patients whose disease responded partially or completely to treatment) of 21.9%, compared with 3.5% among patients treated with Afinitor (everolimus), and 12-month progression-free survival (PFS; the time a patient lives without their disease spreading or worsening) rates were 33.7% on Welireg versus 17.6% with Afinitor, and 18-month PFS rates were 22.5% and 9%, respectively.

“(Welireg) demonstrated a significant improvement in PFS. … Similar findings were noted at the second interim analysis,” study author Dr. Laurence Albiges, medical oncologist and head of the Department of Oncology at Gustave Roussy in Paris, said in a presentation of the findings at ESMO.

The FDA reported that overall survival (OS, the time a patient lives regardless of disease status) remain immature, with 59% of patient deaths reported, but stated that “no trend towards a detriment was observed.”

The recommended dose of Welireg, per the FDA’s announcement, is 120 milligrams orally once a day until disease progression or unacceptable toxicity.

The agency reported that the most common side effects, occurring in at least 25% of patients, included decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium and increased aspartate aminotransferase.

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