EMA Recommends Extension of Indications for Nivolumab

New indication concerns adjuvant treatment of melanoma

On 28 June 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product nivolumab (Opdivo). 

The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG. 

The CHMP adopted a new indication as follows: 

Adjuvant treatment of melanoma 

Opdivo as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. 

For information, the full indication for Opdivo will be as follows 

Melanoma 

Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression. 

Opdivo as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. 

Non-small cell lung cancer (NSCLC) 

Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults. 

Renal cell carcinoma (RCC) 

Opdivo as monotherapy is indicated for the treatment of advanced RCC after prior therapy in adults. 

Classical Hodgkin lymphoma (cHL) 

Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory cHL after autologous stem cell transplant and treatment with brentuximab vedotin. 

Squamous cell cancer of the head and neck (SCCHN) 

Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic SCCHN in adults progressing on or after platinum-based therapy. 

Urothelial carcinoma 

Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. 

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

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.