Merck’s (NYSE:MRK) groundbreaking immunotherapy-drug Keytruda is set to be cleared as an alternative to chemotherapy for lung cancer sufferers in Europe.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion though a final decision wil be made in the first quarter of next year.
Keytruda has already been cleared in Europe for second line use after an initial treatment has failed, but this new approval would mean it would be the first drug a patient receives.
It is one of a new wave of drugs designed to stimulate the immune system to fight off cancerous cells by controlling PD-L1, an antigen that helps regulates the body’s defences.
The CHMP recommendation was for metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have high PD-L1 expression.
“Lung cancer is one of the leading causes of death in the EU, so today’s news is an important step forward for many patients in Europe,” said Dr. Roger Dansey, a senior vice president at Merck.
“If approved, patients with metastatic non-small cell lung cancer with high PD-L1 expression could receive Keytruda instead of chemotherapy as their initial treatment.”
CHMP based its decision on the results of the KEYNOTE-024 trial.