Pembrolizumab — marketed as Keytruda — has been given approval for use across Europe for some patients with a specific kind of bladder cancer, following a decision by the European Commission (EC).
It has agreed that the drug can be marketed for treating adult patients with locally advanced or metastatic urothelial cancer if they have previously been treated with platinum-containing chemotherapy, as well as those who are not eligible for cisplatin-containing chemotherapy.
The EC decision follows a positive opinion from European Medicine Agency’s Committee for Medicinal Products for Human Use, which recommended a change to the terms of the drug’s marketing authorisation.
Pembrolizumab is already approved in Europe as a first-line treatment for some patients with metastatic non-small cell lung carcinoma, patients with relapsed or refractory classical Hodgkin lymphoma and patients with melanoma that has spread or cannot be removed with surgery.
The EC decision comes three months after the US medicines safety watchdog approved pembrolizumab as the first cancer treatment for use against tumours with a common biomarker regardless of where in the body the tumour originated.
The Food and Drug Administration had previously approved it for the treatment of some patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.
Pembrolizumab is marketed by drug manufacturer MSD, which is known as Merck in the United States and Canada.