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Merck : EMA Adopts Positive Opinion For KEYTRUDA

Merck (MRK) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a new extended dosing schedule for KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, for all approved monotherapy indications in the European Union.

In the EU, KEYTRUDA as monotherapy is currently approved for eight indications across five tumor types.

The CHMP positive opinion supports a new recommended dose of 400 mg every six weeks (Q6W) delivered as an intravenous infusion over 30 minutes for KEYTRUDA monotherapy. If approved by the European Commission, the Q6W dose would be available in addition to the currently approved dose of KEYTRUDA 200 mg every three weeks (Q3W) infused over 30 minutes.

The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the EU, and a final decision is expected in the second quarter of 2019.

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. The recommended dose of KEYTRUDA in patients with unresectable or metastatic melanoma is 200 mg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity.

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