According to a recent article, the European Commission (EC) has approved Merck’s KEYTRUDA as an adjuvant treatment for type renal cell carcinoma (RCC), a type of kidney cancer.

Renal Cell Carcinoma (RCC)

Renal cell carcinoma is a type of kidney cancer that spreads easily to the lungs and other organs. There have also been several reports of this “metastatic” renal cell carcinoma in rare sites in the body. However, it usually begins as just one tumor in a kidney, though it can be found in both kidneys at once. Although rare, renal cell carcinoma is the most common kind of kidney cancer in adults. Renal cell carcinoma is more common in males than females and especially common between the ages of 50 and 70.

Symptoms:

Some patients with renal cell carcinoma are asymptomatic, especially early on, and some patients do not have symptoms until cancer has spread to another part of the body. When symptoms occur, they include:

• Blood in the urine (most common) or rusty-colored urine
• Abdominal pain
• Weight loss
• Enlarged testicle or varicose testis vein
• Fever
• Vision abnormalities
• High blood pressure
• Fatigue

KEYTRUDA (Pembrolizumab)

KEYTRUDAis an anti-programmed death receptor-1 therapy, and it is used for patients that are more at-risk of recurrence after nephrectomy or nephrectomy and metastatic lesion resection. It is the first immunotherapy that has been approved in the adjuvant setting for patients diagnosed with renal cell carcinoma.

The Trial

The EC approved KEYTRUDA after the results from a Phase III KEYNOTE-564 clinical trial. The trial was double-blind (both the patient and the doctor do not know whether the patient is receiving the treatment or a placebo), randomized, multicenter, and placebo-controlled. A total of 994 patients with RCC participated in the trial.

The trial resulted in KEYTRUDA significantly improving the disease-free survival (DFS) of its patients. In addition, it lowered both the disease recurrence and mortality risk by 32% after around the two-year mark.

KEYTRUDA will now hit the market as a monotherapy in all member states of the EU in addition to Norway, Iceland, Lichtenstein, and Northern Ireland.