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Friday, June 29, 2018

Bristol gets expanded Euro OK for melanoma med


Bristol-Myers announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has recommended expanded approval of the current indications for Opdivo to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This is the first time the CHMP has recommended a PD-1 inhibitor as an adjuvant treatment for any type of cancer. The CHMP recommendation will now be reviewed by the European Commission, or EC, which has the authority to approve medicines for the European Union

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