Merck known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, Keytruda is recommended for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who are not eligible for cisplatin-containing chemotherapy. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in the third quarter of 2017.

“There is significant need for new options that address the treatment gaps for patients in Europe with locally advanced or metastatic urothelial carcinoma, especially for those who have failed on prior platinum treatment or are ineligible for cisplatin-containing chemotherapy,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are pleased that the CHMP has provided a positive opinion for Keytruda in these two patient populations and look forward to working with the European Commission to bring forward this new option for patients in need.”

The positive opinion is based on data from the KEYNOTE-045 and KEYNOTE-052 trials. KEYNOTE-045 is a phase 3, randomized study investigating Keytruda (pembrolizumab) compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with locally advanced or metastatic urothelial carcinoma that has recurred or progressed on or after platinum-containing chemotherapy. KEYNOTE-052 is a phase 2, open-label study investigating Keytruda in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing therapy.

The Keytruda clinical development programME includes more than 30 tumour types in more than 500 clinical trials, including more than 300 trials that combine Keytruda with other cancer treatments. Currently, Merck has the largest immuno-oncology clinical development program in bladder cancer, with 29 trials underway involving Keytruda as monotherapy and in combination, including four registration-enabling studies.

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumoUr cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumoUr cells and healthy cells.

Studies of Keytruda – from the largest immuno-oncology programME in the industry with more than 500 trials – include a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with Keytruda, including the exploration of several different biomarkers across a broad range of tumoUrs.

Keytruda (pembrolizumab) is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. Keytruda for injection is supplied in a 100 mg single-dose vial in the US.