(Renal Cancer) Keytruda Approved as Adjuvant Therapy — First-Ever for Renal Cell Carcinoma
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- August 31, 2022
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On August 24, 2022, MSD K.K. announced that the anti-PD-1 antibody Keytruda (pembrolizumab) received approval as adjuvant therapy for renal cell carcinoma (RCC) — marking the first-ever approved adjuvant therapy indication for renal cell carcinoma.
Approval Basis
This approval was based on the KEYNOTE-564 Phase 3 clinical trial — an international, multicenter Phase 3 trial enrolling high-risk RCC patients after nephrectomy or partial nephrectomy (N=994 total, including 59 Japanese patients). The trial compared adjuvant Keytruda versus placebo. The primary endpoint of disease-free survival (DFS) was significantly prolonged in the Keytruda group.
Recommended Dosing
- 200 mg every 3 weeks, or 400 mg every 6 weeks
- Both administered as a 30-minute intravenous infusion
- Maximum treatment duration: 12 months
Source: https://www.msd.co.jp/news/product-news-20220824/
- Immunotherapy
- Clinical trial drug
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