FDA Approves Belzutifan with Pembrolizumab as Adjuvant for Renal Cell Carcinoma

FDA approves new adjuvant treatment option for ccRCC patients with recurrence risk

The U.S. Food and Drug Administration (FDA) has approved pembrolizumab, an immunotherapy, plus belzutifan, a HIF-2α inhibitor, as adjuvant treatment for adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, with or without resection of metastatic lesions.

Adjuvant Combination for Kidney Cancer Gets FDA's Blessing

(MedPage Today) -- The FDA on Friday approved belzutifan (Welireg) plus pembrolizumab (Keytruda, Keytruda Qlex) as adjuvant therapy for renal cell carcinoma (RCC) with a clear cell component. Based on results from LITESPARK-022, the combination...

FDA approves belzutifan with pembrolizumab as adjuvant for renal cell carcinoma

The FDA approved belzutifan with pembrolizumab as an adjuvant treatment for adults with clear cell renal cell carcinoma and a high risk for recurrence after nephrectomy, according to a press release.The approval allows belzutifan (Welireg, Merck) to be used in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck).

FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC)

Marks the first approved combinations of a PD-1 and HIF-2α inhibitor Approvals based on Phase 3 LITESPARK-022 trial that showed KEYTRUDA in combination with WELIREG reduced the risk of disease recurrence, metastasis or death by 28% compared to KEYTRUDA plus placebo Represents the first and only global Phase 3 study to have demonstrated an improvement more... The post FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and be…

FDA Approves Adjuvant Belzutifan/Pembrolizumab in Clear Cell RCC Post Nephrectomy

Based on data from the phase 3 LITESPARK-022 trial, the FDA has approved adjuvant belzutifan/pembrolizumab for patients with clear cell RCC.

Dana-Farber Study Backs FDA Approval of Pembrolizumab-Belzutifan Combo for

In a landmark advancement for renal cell carcinoma (RCC) treatment, the U.S. Food and Drug Administration (FDA) has granted approval for a novel adjuvant therapy combining pembrolizumab, a well-known immune checkpoint inhibitor, with belzutifan, a pioneering hypoxia-inducible factor 2-alpha (HIF-2α) inhibitor. This therapeutic regimen is indicated for adult patients diagnosed with clear cell renal cell […]