WASHINGTON — The Food and Drug Administration on Monday approved the use of Keytruda as an adjuvant treatment for patients with certain types of advanced renal cell carcinoma.
Gilead Sciences Inc.’s Keytruda is already approved as a second-line treatment for advanced renal cell carcinoma. The expanded use was part of a trial with 50 additional patients. About 9,250 new cases of kidney cancer were diagnosed in the United States last year, and more than 26,000 new cases of kidney cancer were diagnosed in 2013, according to the National Cancer Institute.
Although existing treatments for advanced renal cell carcinoma are available, the FDA said, some patients could benefit from adding adjuvant treatment to these existing therapies.
“Research has shown that adding a second drug can improve overall survival for certain patients with advanced, difficult-to-treat kidney cancer,” Thomas J. Parker, director of the FDA’s Office of Hematology and Oncology Products, said in a statement.
Keytruda was approved by the FDA last year as a treatment for patients who have overexpressed a protein called PD-L1 on their cancer cells. PD-L1 is an immune system receptor found on a minority of patients’ cells. Having that receptor doesn’t necessarily guarantee a successful treatment, but it makes it easier for the immune system to recognize and attack the cancer cells.
About one in every five patients who receive an initial treatment of at least one drug after being diagnosed with advanced cancer will have an additional response to one or more drugs. However, an additional 5 percent of patients will have an additional response to one or more additional therapies, according to the FDA.
The Keytruda immunotherapy will be available only to patients on new therapy and for patients who have had prior platinum-based chemotherapy therapy for their advanced, resectable or metastatic (serous) kidney cancer. There is no guarantee that patients will benefit from Keytruda adjuvant therapy. It’s still too early to say with certainty which patients will.
The FDA said a warning about potential side effects of Keytruda approved in December 2017 still applies. In clinical trials, the drug was associated with a higher risk of neuropathy, which is a numb feeling in the fingertips or feet, and nausea, vomiting and diarrhea.
In clinical trials, Keytruda was also associated with a higher risk of infusion-related reactions, which cause a wide range of symptoms such as fever, breathing difficulties, fatigue, abdominal pain, vomiting, and decreased mental alertness. Most of the reactions are mild, but 3.6 percent were severe.