EMA Advisory Committee OKs Combination Use for BMS’ Drugs for Melanoma
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Bristol-Myers Squibb’s immunotherapy, Opdivo (nivolumab), in combination with the company’s Yervoy (ipilimumab) for the treatment of advanced (unresectable or metastatic) melanoma in adults.

The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC) and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma.

Source: Bristol-Myers Squibb

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