FDA approves Keytruda-Welireg regimen for high-risk kidney cancer after surgery

The US Food and Drug Administration (FDA) has approved Merck & Co’s (NYSE: MRK) Welireg (belzutifan) in combination with Keytruda (pembrolizumab), or the subcutaneous formulation Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), for the adjuvant treatment of adults with renal cell carcinoma (RCC) with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy.

This approval also covers patients who have undergone nephrectomy and resection of metastatic lesions. Merck said the decision marks the first approval of PD-1 and hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor combination regimens.