FDA approves Keytruda for adjuvant treatment of renal cell carcinoma

fda approves keytruda for adjuvant treatment of renal cell carcinoma

Sumary of FDA approves Keytruda for adjuvant treatment of renal cell carcinoma:

  • Back to Healio The FDA expanded the approval of pembrolizumab to include adjuvant treatment of certain patients with renal cell carcinoma.
  • The indication applies to use of the agent by patients at intermediate-high or high risk for recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
  • The FDA based the new indication on results of the randomized phase 3 KEYNOTE-564 trial, which included 994 patients with renal cell carcinoma at intermediate-high or high risk for recurrence.
  • Researchers assigned patients to 200 mg pembrolizumab via IV or placebo on day 1 of each 3-week cycle.
  • As Healio previously reported, results showed a statistically significant improvement in DFS among patients assigned pembrolizumab (HR = 0.68;
  • “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.
  • ” The most common adverse events reported among pembrolizumab-treated patients included musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%) and hypothyroidism (21%).

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