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Merck's KEYTRUDA Approved By Health Canada As First-line Treatment In Metastatic Recurrent HNSCC

Merck & Co. Inc. (MRK) announced Thursday that Health Canada has approved its anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma or HNSCC as monotherapy. The treatment is for adult patients whose tumours have PD-L1 expression as determined by a validated test.

The health agency has also approved KEYTRUDA for the first-line treatment of metastatic or unresectable recurrent HNSCC in combination with platinum and fluorouracil or FU chemotherapy, in adult patients.

KEYTRUDA is an anti-PD-1 therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells.

Health Canada's approval for HNSCC is based on significant overall survival findings from Phase 3 KEYNOTE-048 trial.

KEYTRUDA was first approved in Canada in 2015 and currently has 16 indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, classical Hodgkin lymphoma and melanoma.

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