FDA Accepts sNDA for New Use for Merck’s Keytruda

Merck & Co. report that the US Food and Drug Administration (FDA) has accepted for review a new supplemental biologics license application (sBLA) for Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for treating advanced non-small cell lung cancer.

Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

It is approved in the US for treating unresectable or metastatic melanoma. It is also approved for treating metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.

Source: Merck & Co.

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