Policy & Regulation
USFDA approves Merck's anti-PD-1 therapy Keytruda
13 June 2019 -

United States Food and Drug Administration (USFDA) has approved United States-based Merck's anti-PD-1 therapy Keytruda (pembrolizumab) intended for treatment of head and neck cancer, it was reported yesterday.

The regulator has approved the product as monotherapy and in combination with chemotherapy regimen platinum and fluorouracil. The approval is for first-line treatment of metastatic or with unresectable, recurrent head and neck squamous cell carcinoma as monotherapy in patients whose tumours express the biomarker PD-L1.

The drug's approval in combination with fluorouracil is for the treatment of the same condition, irrespective of PD-L1 expression.

The product received extended approval as a result of the findings of a phase three KEYNOTE-048 trial in which the product significantly improved overall survival in comparison to the EXTREME regimen (cetuximab with carboplatin or cisplatin plus fluorouracil). This was showcased with the drug used as monotherapy and in combination with chemotherapy.



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