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European Commission approves Opdivo(nivolumab) for treatment of advanced metastatic melanoma- BMS

Read time: 1 mins
Last updated: 19th Jun 2015
Published: 19th Jun 2015
Source: Pharmawand

BMS announced that the European Commission has approved Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. This approval allows for the marketing of Opdivo in all 28 Member States of the EU. It follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), which was announced on April 24, 2015. Opdivo is the only PD-1 immune checkpoint inhibitor to receive an accelerated assessment in Europe, and is the first approval given by the European Commission for a PD-1 inhibitor in any cancer.

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