Merck follows Bristol with EU green light for immune cancer drug

[May 22, 2015]  (Reuters) - European regulators have recommended approval of Merck & Co Inc's immune system-boosting cancer drug Keytruda, following a similar green light last month for Bristol-Myers Squibb Co's rival product Opdivo.

Merck's drug, also known as pembrolizumab, was endorsed on Friday by the European Medicines Agency (EMA) for the treatment of melanoma.

Both Keytruda and Opdivo are already approved in the United States.

The EMA said Keytruda was recommended for use on its own for the treatment of advanced melanoma, the most aggressive type of skin cancer, in both first-line and previously treated patients. (http://bit.ly/1FrWjYm)

Keytruda and Opdivo belong to a highly promising new class of medicines called PD-1 inhibitors that block a mechanism tumors use to hide from the immune system. It is expected to be one of the most commercially successful new drugs to reach major markets this year.

Although Keytruda is still waiting for final regulatory approval in Europe, some patients in Britain are receiving it through a new early-access scheme, under which highly promising new drugs are made available free of charge ahead of formal licensing.

Friday's positive European opinion on Keytruda is an intermediary step on the drug's path to market, since it now has to be sent to the European Commission for formal adoption. After that, decisions on price and reimbursement will taken by individual governments around Europe.

(Reporting by Ben Hirschler in London and Esha Vaish in Bengaluru; Editing by Sriraj Kalluvila)

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