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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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