European Medicines Agency Recommends Granting a Marketing Authorisation for Nivolumab

It is intended for the treatment of advanced melanoma

On 23 April 2015, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product nivolumab (Opdivo), intended for the treatment of advanced (unresectable or metastatic) melanoma in adults.

The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

Opdivo will be available as a 10 mg/ml concentrate for solution for infusion. The active substance of Opdivo is nivolumab, antineoplastic monoclonal antibody (ATC code L01XC17). Opdivo potentiates T cell responses, including anti-tumour responses, through blockade of PD 1 binding to PD L1 and PD L2 ligands.

The benefits obtained with nivolumab are an increase in overall survival over dacarbazine (HR 0.42; p < 0.0001) in adult patients with advanced (unresectable or metastatic) melanoma who have not received prior therapy and an improvement in overall response rate for nivolumab compared to investigator’s choice of treatment (31.7% vs. 10.6%, respectively) in adults who had received previous therapy.

The most common side effects are fatigue, pruritus, nausea, diarrhoea, and rash. Nivolumab is associated with immune-related adverse reactions including endocrine abnormalities, diarrhoea/colitis, hepatitis, pneumonitis, nephritis and rash.

The full indication is: "Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults".

It is proposed that Opdivo be prescribed by physicians experienced in the treatment of cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.