Merck has received a positive opinion from European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Keytruda (pembrolizumab) to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC).
Keytruda (pembrolizumab) is a humanised, monoclonal antibody that functions by increasing the ability of the body’s immune system to help detect, as well as fight tumour cells.
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It is an anti-programmed death-1 (PD-1) therapy and can be used to treat adults whose tumours show programmed death ligand-1 (PD-L1) and who have received at least one prior chemotherapy regimen.
Adult patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) tumour mutations should also have received approved therapy for these mutations before receiving pembrolizumab.
The positive opinion granted by CHMP for pembrolizumab will now be reviewed by the European Commission (EC) for approving marketing authorisation in the European Union (EU).
Merck research laboratories oncology late-stage development senior vice-president and therapeutic area head Dr 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.
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By GlobalData"We are grateful to patients and investigators around the world who participated in these studies and who are helping to advance this important new treatment."
The CHMP positive opinion was based on the data collected from the findings of two studies, Keynote-010, the major study assessing overall survival (OS), and Keynote-001, which assessed overall response rates (ORR).
The CHMP recommended approval of single-agent keytruda at a dose of 2mg/kg every three weeks.
The dose is also approved by the US Food and Drug Administration (FDA) for advanced NSCLC in the country.
A final decision based on the CHMP recommendation regarding the approval of pembrolizumab is expected in the third quarter of this year from EC.
