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Kidney cancer: a new indication approved for Keytruda


Health Canada has approved Keytruda® (pembrolizumab) from Merck as adjuvant therapy in certain adults with renal cell carcinoma.

The treatment is approved for patients who have a moderate to high risk of recurrence, following nephrectomy or nephrectomy accompanied by surgical resection of metastatic lesions.

According to data from the Kidney Cancer Research Network of Canada, renal cell carcinoma accounts for more than 90% of kidney cancer cases.

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It is one of the deadliest genitourinary cancers, as the five-year survival rate is only 7%. It tends to be more common in men, as well as in people over the age of 50.

Clinical study

Health Canada's approval stems from the results of the Phase III KEYNOTE-564 study. A total of 994 patients were included in the study, of which 496 patients were randomized to receive pembrolizumab and 498 placebo.

However, the treatment was associated with a disease-free survival at 24 months that was significantly longer than the placebo (77.3% versus 68.1%). “The most common treatment-related adverse events (reported in at least 10% of patients) were fatigue, pruritus, hypothyroidism, diarrhea, rash, and hyperthyroidism,” notes the product monograph.

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Health Canada's decision comes one month after Health Canada approved Keytruda® for the treatment of stage IIB or IIC melanoma after complete resection.

The drug is already approved for several diseases such as bladder cancer, non-small cell carcinoma, advanced stage renal cell carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin's lymphoma, colorectal cancer, endometrial carcinoma, esophageal cancer, triple negative breast cancer, melanoma and head and neck squamous cell carcinoma.

This article has been translated from its original French and originally appeared on our sister site Profession Santé.

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