Policy & Regulation
USFDA approves Merck's Keytruda and Eisai's Lenvima
19 September 2019 -

It was reported yesterday that the US Food and Drug Administration (USFDA) has approved United States-based Merck's Keytruda (pembrolizumab) plus Japan-based Eisai's Lenvima (lenvatinib) intended to treat patients with certain types of endometrial carcinoma.

Keytruda is a humanised monoclonal antibody, which blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, and is likely to affect both tumour cells and healthy cells, while Lenvima is a kinase inhibitor, which blocks the kinase activities of vascular endothelial growth factor receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).

Study patients had been treated with Keytruda 200mg intravenously every three weeks in combination with Lenvima 20mg once daily.

The products' approval was based on data from KEYNOTE-146/Study 111, a phase two, multi-cohort, multicentre, open-label and single-arm trial that recruited 108 patients with metastatic endometrial carcinoma.