FDA Grants Approval to Keytruda for Early Stage RCC

The FDA has approved Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma (RCC) who are at a high risk of recurrence. This approval is the fourth indication in earlier stages of cancer. Other early cancer indications include: early stage, triple negative breast cancer; as a first-line treatment of head and neck cancer; and as a first-line treatment in nonsmall cell lung cancer.

The RCC indication is based on a phase 3 trial in which Keytruda demonstrated an improvement in disease-free survival. The median duration of response was 11.1 months. Severe reactions occurred in 20% of patients and included: acute renal injury, adrenal insufficiency, pneumonia, colitis and diabetic ketoacidosis. The trial is ongoing to assess overall survival as a secondary outcome measure.

Toni K. Choueiri, M.D.

“Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence. In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence,” Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School. “With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients.”

Renal cell carcinoma is the most common type of kidney cancer; it is more common in men than women. The National Institutes of Health estimates that in 2021, 76,000 new cases will be diagnosed, and there will be almost 14,000 deaths.