EMA Advisory Committee Recommends New Use for Merck’s Cancer Drug Keytruda
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Merck & Co.’s Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. The CHMP positive opinion for Keytruda will now be reviewed by the European Commission for marketing authorization in the European Union (EU).

The CHMP recommended approval of Keytruda monotherapy at a dose of 2 mg/kg every three weeks, which is also the FDA-approved dose for metastatic NSCLC in the United States. Based on this recommendation, a final decision regarding the approval of Keytruda monotherapy is expected from the European Commission in the third-quarter of 2016.

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. It 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.

Keytruda is now indicated for the treatment of patients with unresectable or metastatic melanoma. In the United States, Keytruda is also indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) 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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