Merck & Co. Inc. said the European Commission approved Keytruda combined with chemotherapy as a first-line treatment for certain lung cancer patients.
The EU regulator gave the nod to Keytruda, in combination with chemotherapy drugs — carboplatin and either paclitaxel or nab-paclitaxel — for treating adults with squamous non-small cell lung cancer, or NSCLC, that has spread across the body. Keytruda was approved in the U.S. for the same indication in October 2018.
The approval is based on data from a phase 3 trial, called Keynote-407, which showed that the treatment regimen prolonged the survival of patients squamous NSCLC whose diseases have spread.
Keytruda, or pembrolizumab, is a checkpoint inhibitor — a tumor-targeting drug that blocks the PD-1 arm on healthy cells from linking up with a partner arm on the surface of cancer cells to spread the disease.
Keytruda is also approved in the EU combined with Eli Lilly and Co.'s Alimta and chemotherapy for treating metastatic nonsquamous NSCLC in adults whose tumors do not have certain genetic mutations known as EGFR or ALK positive and as a monotherapy for treating metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumors have high PD-L1 expression with no EGFR or ALK-positive tumor mutations.
The therapy is also approved in Europe for treating locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
Lung cancer is the leading cause of cancer death in Europe, with the region recording about 388,000 deaths from the disease in 2018.
Keytruda is already approved in the U.S., EU and elsewhere for multiple cancer indications.