EMA committee recommends approval of Merck’s Keytruda for advanced NSCLC

The CHMP has specifically recommended approval of the therapy for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen.

The positive opinion will now be reviewed by the European Commission for marketing authorisation in the European Union.

Data supporting the CHMP opinion were based on two studies, KEYNOTE-010 and KEYNOTE-001, under which overall survival and overall response rates were evaluated.

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 US.

Based on this recommendation, a final decision regarding the approval of the therapy is expected from the European Commission in the third-quarter of this year.

Merck Research Laboratories senior vice president and therapeutic area head, oncology late-stage development Roger Dansey said: "This news marks an important step in making Keytruda available for appropriate patients suffering from locally advanced or metastatic 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 identify 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.