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Home Industry News Merck Sharp and Dohme’s Keytruda recommended for EU bladder cancer approval

Merck Sharp and Dohme’s Keytruda recommended for EU bladder cancer approval

25th July 2017

Merck Sharp and Dohme has announced that its cancer drug Keytruda has been recommended for EU approval in a new bladder cancer indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of the anti-PD-1 therapy for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma.

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 those who are not eligible for cisplatin-containing chemotherapy.

This recommendation was based on positive safety and efficacy data from the KEYNOTE-045 and KEYNOTE-052 trials, and will now be reviewed by the European Commission ahead of a final decision expected in the third quarter of 2017.

Dr Roger Dansey, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "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."

This comes after the drug was accepted for inclusion in England's Cancer Drugs Fund as a first-line lung cancer therapy earlier this month.

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