The approval follows statistically significant improved disease-free survival results.
The Food and Drug Administration has approved Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma, a type of kidney cancer, who are at intermediate-high or high risk of recurrence following nephrectomy (surgical kidney removal) or following nephrectomy and resection of metastatic lesions.
The approval comes following the KEYNOTE-564 trial, which evaluated the efficacy of Keytruda in the adjuvant setting for this patient population. Patients were administered either 200 milligrams of Keytruda intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity.
Results demonstrated a statistically significant improvement of disease-free survival (defined as the time from treatment to recurrence, metastasis, or death) with 109 (22%) events in the Keytruda group and 151 (30%) events in the placebo group; median disease-free survival was not met in either group.
At the time of analysis, overall survival was not mature with 5% of deaths occurring in the population.
The recommended dose for Keytruda in this setting is 200 milligrams every three weeks or 400 milligrams every six weeks until disease recurrence, unacceptable toxicity, or up to 12 months.
The most common side effects occurred more than 20% of the time and included musculoskeletal pain, fatigue, rash, diarrhea, itchy skin and hypothyroidism
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