MSD scores EU approval for Keytruda in lung cancer
pharmafile | August 3, 2016 | News story | Research and Development, Sales and Marketing | EU, MSD, Merck, approval, keytruda, lung cancer
MSD, called Merck in the US and Canada, has announced that the European Commission has approved Keytruda (pembrolizumab) for patients with locally advanced or metastatic non-small cell lung cancer in patients whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen.
The drug, which is already approved in the EU for melanoma, is MSD’s leading anti-PD-1 therapy and a main rival for Bristol-Myers Squibb’s Opdivo. This latest approval for Keytruda is based on findings from the late-stage KEYNOTE-010 trial, which showed a significant improvement in overall survival compared to standard of care chemotherapy.
Each year, more people die of lung cancer than die of colon, breast and prostate cancers combined. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 85% of cases. The five year survival rate for patients suffering from advanced forms of the disease is estimated to be only 2%.
Dr Roger Dansey, senior VP in oncology late-stage development at MSD, says: “This approval provides an important new treatment regimen for patients in Europe with advanced lung cancer, one of the most common and challenging cancers.”
Dr Luis Paz-Ares, chair of the medical oncology department at Hopsital Universitario in Madrid, comments: “The survival benefit for Keytruda observed in previously-treated patients who express PD-L1 is promising. There is a significant unmet need for lung cancer patients who are most likely to benefit from treatment.”
Sean Murray
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