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Home Industry News Merck Sharp and Dohme receives CHMP backing for new Keytruda approval

Merck Sharp and Dohme receives CHMP backing for new Keytruda approval

27th March 2017

Merck Sharp and Dohme has announced that its cancer therapy Keytruda has been recommended for European approval in a new 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 adult patients with relapsed or refractory classical Hodgkin lymphoma.

Keytruda is specifically intended for patients who have failed treatment with autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible. A final decision on approval in this indication is expected in the second quarter of 2017.

The application was supported by data from the KEYNOTE-087 and KEYNOTE-013 trials, which demonstrated the safety and efficacy of Keytruda in this new indication.

Dr Roger Dansey, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "This CHMP positive recommendation brings us one step closer to offering appropriate patients in the European Union with classical Hodgkin lymphoma a new treatment option to help fight this haematologic cancer."

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