The US Food and Drug Administration (FDA) has approved MSD’s Keytruda (pembrolizumab), in combination with Inlyta(axitinib), as first-line treatment for patients with advanced renal cell carcinoma (RCC).

The approval is based on results of the KEYNOTE-426 study, in which the combination was found to reduce the risk of death by nearly half compared to Pfizer's Sutent (sunitinib).

The data showed a reduction in risk of death of 47% compared to sunitinib, and in risk of progression of disease by 31%.

The approval marks the first indication for Keytruda in advanced RCC, the most common type of kidney cancer, and the first anti-PD-1 therapy FDA-approved as part of a combination regimen that significantly improved overall survival, progression free survival and overall response rate versus sunitinib in patients with advanced RCC, the firm noted.

“This represents a new treatment option for patients with advanced renal cell carcinoma, who will now have access to Keytruda as part of a first-line combination regimen,” said Dr Scot Ebbinghaus, vice president, clinical research, MSD’ Research Laboratories. “Today’s approval reflects MSD’s commitment to patients with cancer and further supports the use of Keytruda to help improve survival outcomes for patients with advanced renal cell carcinoma.”

The FDA recently approved an expanded label for Keytruda, for the first-line treatment of certain patients with stage III non-small cell lung cancer (NSCLC).

RCC is a kidney cancer that originates in the lining of the proximal convoluted tubule, a part of the very small tubes in the kidney that transport primary urine. It is the most common type of kidney cancer in adults, responsible for approximately 90–95% of cases.