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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
161 working days (255)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Head and Neck Squamous Cell Cancer (HNSCC)
KEYTRUDA® (powder for injection, concentrated solution for injection), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
KEYTRUDA® is now also indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.