MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer
pharmafile | June 28, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | CHMP, EMA, MSD, Merck & Co, keytruda, lung cancer
MSD (Merck & Co) said its anti-programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab) to treat lung cancer has secured a positive opinion for a recommendation from of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology, said: “Today’s news marks an important step in our ongoing efforts to bring forward a personalised treatment approach to identify advanced lung cancer patients who are most likely to benefit from pembrolizumab. The CHMP positive opinion along with last year’s EMA approval in advanced melanoma underscores our commitment to working closely with the European health authorities to expand access to pembrolizumab for those patients most in need.”
The CHMP recommended approval of single-agent pembrolizumab at a dose of 2 mg/kg every three weeks, which is also the FDA-approved dose for advanced NSCLC in the US. Based on this CHMP recommendation, a final decision regarding the approval of single-agent pembrolizumab is expected from the European Commission in the third-quarter of 2016.
Pembrolizumab is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications. It is indicated in the EU as a monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Pembrolizumab is a humanised monoclonal antibody, one of the first of a new generation of therapies that work by blocking the biological pathways cancers use to disguise themselves from the immune system. Specifically, it blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumour immune response.
Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Non-small cell lung cancer is a disease in which malignant cells form in the tissues of the lung.
Anjali Shukla
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