FDA approve Keytruda as adjuvant treatment for kidney cancer

pharmafile | November 19, 2021 | News story | Medical Communications  

The FDA has approved Keytruda® for the treatment of patients with early renal cell carcinoma at high or intermediate-high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Keytruda is typically used to treat advanced types of cancers such as lung cancer and melanoma, by working with a patient’s immune system. The PD-1 inhibitor is the first immunotherapy to enter the field.

This approval is based on data from the Phase III KEYNOTE-564 trial, which demonstrated a statistically significant improvement in disease-free survival, reducing the risk of disease recurrence or death by 32% in patients treated with Keytruda compared to placebo. Prior to Keytruda’s approval, Pfizer’s kinase inhibitor Sutent was approved in 2017 as an adjuvant therapy to prevent kidney cancer from recurring in high-risk patients. This treatment has not become standard-of-care, however, due to limited efficacy and a high rate of side effects.

Dr Toni K Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School, commented: “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.”

Adjuvant treatment is a therapy used to enhance the effects of the primary treatment regimen of a disease. Treatment options available for those with RCC are limited, and this patient population is often at risk for recurrence.

Dr Choueiri added: “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.”

Ana Ovey

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