The European Medicines Agency (EMA) has adopted a positive opinion recommending approval of pembrolizumab, an anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Specifically, pembrolizumab 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, with final decision is expected in late 2017.

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably, and can spread to other areas of the body. 

Urothelial carcinoma, the most common type of bladder cancer, starts in the urothelial cells that line the inside of the bladder.

In 2012, approximately 430,000 people worldwide were diagnosed with bladder cancer and 165,000 died from the disease. 

The positive opinion is based on data from the KEYNOTE-045 and KEYNOTE-052 trials.

KEYNOTE-045 is a phase 3, randomised study investigating 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 pembrolizumab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing therapy.

“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. 

Source: BusinessWire