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MSD’s Keytruda wins bladder cancer indication in Japan

Becomes first anti-PD1 approved in the country for previously treated UC

Keytruda

Bladder cancer patients living in Japan can now access Merck Sharp and Dohme’s (MSD) Keytruda (pembrolizumab) following a green light from the Japanese Ministry of Health, Labour and Welfare (MHLW).

The pharma giant’s blockbuster has gained a new indication to treat patients with previously treated urothelial carcinoma (UC) that is unresectable with radical surgery and whose disease has progressed following chemotherapy.

Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said: “Chemotherapy has long been the standard of care for advanced urothelial carcinoma, with few options available for patients whose disease progresses.”

The approval marks additional positive news for MSD, as it makes Keytruda the first anti-PD1 therapy approved in the country for this indication.

Baynes added: “We welcome the approval of Keytruda as the first anti-PD-1 therapy for these patients in Japan based on the compelling overall survival data.”

Keynote-045 - a randomised, controlled phase III trial - investigated Keytruda in patients with locally advanced or metastatic UC with disease progression on or after platinum-containing chemotherapy.

The study demonstrated a statistically significant improvement in OS compared to chemotherapy, including a 27% reduction in risk of death with Keytruda and a median OS of 10.3 months compared to 7.4 months with chemotherapy.

Keytruda is now indicated for use in four types of cancer in Japan, including for the treatment of radically unresectable melanoma, PD-L1-positive unresectable advanced or recurrent non-small cell lung cancer, and relapsed of refractory classical Hodgkin lymphoma.

To date, the medication has racked up approvals seven indications including melanoma, blood cancer and bladder cancer globally.

Article by
Gemma Jones

2nd January 2018

From: Regulatory

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