Keytruda is an anti-PD-1 therapy, which works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
It is a humanized monoclonal antibody that halts the interaction between PD-1 and its ligands, PD-L1 and PD-L2, helping to activate T lymphocytes that may affect both tumor cells and healthy cells.
The approval allows the company to sell Keytruda in these two new indications in all 28 EU member states, as well as Iceland, Lichtenstein and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
The approval in patients previously treated with platinum-containing chemotherapy is based on data from Keynote-045 trial, which assessed Keytruda in patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy.
According to the company, Keytruda showed a statistically significant improvement in overall survival (OS) compared to chemotherapy.
Keytruda was also approved to treat patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
Merck Research Laboratories oncology late-stage development therapeutic area head and senior vice president Dr Roger Dansey said: "This approval of Keytruda is important for patients with advanced urothelial carcinoma.
“Our focus is now on working with health authorities in Europe to ensure access for these patients as quickly as possible.”
Image: Keytruda secured EC approval to treat locally advanced or metastatic urothelial carcinoma. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.