• Blood Cancers
  • Genitourinary Cancers
  • Brain Cancer
  • Breast Cancer
  • Childhood Cancers
  • Gastric Cancers
  • Gynecologic Cancer
  • Head & Neck Cancer
  • Immunotherapy
  • Leukemia
  • Lung Cancer
  • Lymphoma
  • Myeloma
  • Rare Cancers
  • Sarcoma
  • Skin Cancer
  • Thyroid Cancer

FDA Approves Welireg for Advanced Kidney Cancer Subtype

News
Article

The Food and Drug Administration has approved Welireg for patients with advanced renal cell carcinoma, a type of kidney cancer, following treatment with a PD-1 or PD-L1 inhibitor and a VEGF-TKI.

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.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Related Videos
Man in a navy suit with a purple tie. Dr. Saby George talks to CURE about how treatment with Opdivo could mitigate disparities in patients with kidney cancer.
Tian Zhang, MD, MHS, an expert on renal cell carcinoma
Chandler H. Park, MD, an expert on renal cell carcinoma
Tian Zhang, MD, MHS, an expert on renal cell carcinoma
Chandler H. Park, MD, an expert on renal cell carcinoma
Tian Zhang, MD, MHS, an expert on renal cell carcinoma
Chandler H. Park, MD, an expert on renal cell carcinoma
Tian Zhang, MD, MHS, an expert on renal cell carcinoma
Chandler H. Park, MD, an expert on renal cell carcinoma
Tian Zhang, MD, MHS, an expert on kidney cancer
Related Content