Merck: positive opinion on Keytruda from EU medicines agency
(CercleFinance.com) - A European Medicines Agency (EMA) panel has recommended extending the dosing of Keytrauda, Merck's key cancer drug, the company said on Monday.
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 Merck's immunotherapy for all approved indications in the European Union.
The CHMP's positive opinion supports a new recommended dose of 400 mg every six weeks delivered as an intravenous infusion over 30 minutes, doubling the currently approved dose of 200 mg every three weeks.
In the EU, Keytruda as is currently approved for five types of tumour.
A final decision is expected in the second quarter of 2019, Merck said.
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