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%).