Merck secures EC approval for Keytruda in combination therapy for lung cancer

Merck has achieved a significant milestone by obtaining approval from the European Commission (EC) for its cancer immunotherapy, Keytruda (pembrolizumab), to be used in combination with Eli Lilly’s chemotherapy drug pemetrexed (ALIMTA) and platinum chemotherapy. This approval specifically targets the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults who do not have EGFR or ALK genomic tumor aberrations.

With this approval, Merck is now authorized to market the Keytruda chemotherapy combination across all 28 European Union member states, as well as in Norway, Iceland, and Liechtenstein. This expands the availability of this promising cancer treatment to a broader European audience.

The approved dosage of Keytruda for this combination therapy is 200mg, administered once every three weeks. Treatment is to continue until disease progression is observed or toxicity levels become unacceptable. Keytruda works by enhancing the immune system‘s ability to detect and destroy tumor cells, operating as a humanized monoclonal antibody that inhibits the PD-1/PD-L1 pathway and activates T lymphocytes.

Frank Clyburn, President of Merck Oncology, emphasized the importance of this approval: “Lung cancer is the leading cause of cancer death in Europe, and we are committed to doing everything in our power to help address it. Today, KEYTRUDA is now approved across Europe for the treatment of appropriate patients with metastatic nonsquamous non-small cell lung cancer as both a monotherapy and in combination with chemotherapy.”

The approval was based on results from the Keynote-189 phase 3 trial, which demonstrated significant survival benefits of the Keytruda combination therapy compared to standard-of-care chemotherapy alone. The trial included metastatic nonsquamous NSCLC patients with varying levels of PD-L1 tumor expression and showed that the combination therapy reduced the risk of death by 50% among its patients.

Dr. Roger M. Perlmutter, President of Merck Research Laboratories, highlighted the importance of this advancement: “We are very pleased that the European Commission has approved KEYTRUDA in combination with chemotherapy based on the significant survival benefit demonstrated in the KEYNOTE-189 trial. This approval is a first in Europe and adds to the rapidly growing role of KEYTRUDA as a foundation for the treatment of lung cancer.”

This approval marks a pivotal advancement in the treatment of lung cancer in Europe, offering new hope to patients facing this challenging disease. Merck’s combination therapy represents a significant step forward in oncology, promising to improve survival rates and quality of life for many patients.