Bristol-Myers Squibb Co. (NYSE:BMY) said the European Commission approved Opdivo nivolumab in combination with Yervoy ipilimumab to treat advanced melanoma in adults independent of BRAF mutation status. The company said it is the first combination of two immuno-oncology therapies to be approved in the EU.
BMS markets both drugs. Opdivo, a human IgG4 against PD-1, is approved in the EU as monotherapy to treat locally advanced melanoma, and to treat advanced or metastatic squamous non-small cell lung cancer (NSCLC). Yervoy, a human mAb against CTLA-4 (CD152), is also approved as monotherapy in the EU to treat advanced melanoma.