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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
226 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
KEYTRUDA (pembrolizumab), as monotherapy, is now also indicated for the adjuvant treatment of patients with RCC with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (see section 5.1, Clinical Trials: Renal Cell Carcinoma).