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MSD's Keytruda wins new bladder cancer indication in Europe

Will treat locally advanced or mUC patients

Keytruda

Merck Sharp and Dohme’s (MSD) monoclonal anti-PD-1 therapy Keytruda (pembrolizumab) has won a new indication in Europe for patients with locally advanced or metastatic urothelial carcinoma (mUC), the most common type of bladder cancer.

More specifically, the treatment will be available for adults who have received prior platinum-containing therapy or adults who aren’t eligible for cisplatin-containing chemotherapy.

This type of chemotherapy has long been the standard of care as a first-line treatment, however around half of patients aren’t eligible for this.

Dr Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development at Merck Research Laboratories, said: “This approval of Keytruda is important for patients with advanced metastatic urothelial carcinoma.”

In 2012, approximately 430,000 people worldwide were diagnosed with bladder cancer and 165,000 died from the disease, according to MSD (known as Merck & Co in the US and Canada).

Dansey added: “Our focus is now on working with health authorities in Europe to ensure access for these patients as quickly as possible.”

The European Commission’s green light for Keytruda was based on the randomised phase III KEYNOTE-045 trial, which resulted in a 27% reduction in risk of death compared to patients on investigator-choice chemotherapy (paclitaxel, docetaxel, vinflumime).

Ronald de Wit of the Erasmus MC Cancer Institute said: “It is exciting that with this approval of Keytruda, we now also have a new treatment option that has shown a clinically meaningful and improved overall survival benefit versus chemotherapy in this difficult-to-treat population.”

The intravenous injection was also approved as a first-line therapy for patients with mUC in the US last May, seeing Merck & Co compete against Roche’s Tecentriq (atezolizumab), which brought in CHF 157m in sales last year - mostly from the US.

Article by
Gemma Jones

20th September 2017

From: Regulatory

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