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FDA Grants Approval to Keytruda for Early Stage RCC


Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.

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.

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.

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