Friday, April 24, 2015

EU recommends immune system Cancer drug


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.

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