Merck (or MSD as it is called outside the U.S. and Canada), recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of the drug Keytruda (pembrolizumab) to be used in certain types of lung cancer.
The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and brings the drug one step closer to the market in Europe. A final decision from the European Commission is expected by the end of 2016.
The CHMP’s positive opinion is based on the results of two clinical trials. The first one, called Keynote-010, is a Phase 2/3 trial assessing the overall survival of patients. In the study, patients were given two different doses of Keytruda every three weeks, and their survival compared to patients who were given a standard chemotherapy drug.
The second trial, Keynote-001, evaluated overall response rates to Keytruda when given every three weeks at the same two doses.
In a news release from the company, Dr. Roger Dansey, senior vice president and therapeutic area head in oncology late-stage development at Merck Research Laboratories, thanked “patients and investigators around the world who participated in these studies and who are helping to advance this important new treatment.”
“This news marks an important step in making Keytruda available for appropriate patients suffering from locally advanced or metastatic non-small cell lung cancer,” he said.
Keytruda is already being used to treat patients with metastatic skin cancer. It is also approved in the U.S. to treat patients with metastatic non-small cell lung cancer (NSCLC) expressing a protein called PD-L1, and who have already received at least one regimen of chemotherapy.
The drug works by increasing the ability of the immune system to detect and destroy tumor cells. Some tumor cells produce a protein called PD-L1, which binds to a receptor found on the surface of specialized immune cells called T-cells.
By doing so, they “blind” these immune cells and “escape” them. Keytruda blocks the interaction between PD-L1 and its receptor on the surface of T-cells, thereby allowing T-cells to detect and destroy tumor cells.
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