LONDON (Reuters) - European regulators have recommended approval of Bristol-Myers Squibb’s Opdivo, paving the way for it to become the first of a closely watched group of immune system-boosting cancer medicines to go on sale in Europe.
The drug, also known as nivolumab, was given a green light on Friday by the European Medicines Agency (EMA) for the treatment of melanoma. It is already approved in the United States for melanoma and lung cancer.
The EMA said Opdivo 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.
The agency also recommended approval of Daiichi Sankyo’s Lixiana, or edoxaban, for stroke prevention and Vanda Pharma’s Hetlioz, or tasimelteon, to treat a sleep-wake disorder in blind people.
Bristol’s Opdivo belongs to a highly promising new class of medicines called PD-1 inhibitors that block a mechanism tumours 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.
It competes with Merck & Co’s Keytruda, which is also on the market in the United States but not in Europe.
Although Keytruda is still waiting for regulatory approval in Europe, some patients in Britain will soon receive 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 Opdivo 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.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) had initially looked at Opdivo last month but it postponed a decision at that time.
(This version of the story adds detail on PD-1 drugs, other EMA recommendations)
Reporting by Ben Hirschler; Editing by Jane Merriman and Pravin Char