EMA Recommends Extending the Use of Nivolumab

New indications concern the treatment of renal cell carcinoma and non-squamous NSCLC

On 25 February 2016, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions recommending changes to the terms of the marketing authorisation for the medicinal product nivolumab (Opdivo). The CHMP has recommended extending the use nivolumab to include the treatment of adult patients with advanced renal cell carcinoma who have received prior therapy. Another extension of indication recommends use of nivolumab as a monotherapy in locally-advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

Nivolumab was first authorised in the European Union (EU) in June 2015 for the treatment of advanced melanoma and already had its use extended in October 2015 to treatment of the advanced stages of squamous NSCLC.

The active substance in Opdivo – nivolumab – is a monoclonal antibody. Nivolumab attaches to and blocks a receptor called programmed death-1 (PD-1). By blocking the usual receptor interactions, nivolumab leads to activation of the immune system against cancer cells.

The recommendation from the EMA’s CHMP is based on the results of a randomised phase III study evaluating nivolumab versus everolimus. In total, 821 patients with locally advanced or metastatic renal cell carcinoma whose disease progressed during or after treatment with anti-angiogenic therapy were included in the study.

The median survival time after starting treatment in patients taking nivolumab was 25 months compared to just under 20 months in patients treated with everolimus.

In addition, about 22% of patients taking nivolumab saw a complete or partial shrinkage of their tumours compared to 4% of those taking everolimus; on average the effect lasted around 12 months for both groups.

The most common side effects of nivolumab reported during the clinical trial were similar to those observed in the already approved indications of nivolumab. These include fatigue, nausea, rash, diarrhoea and decreased appetite.

Another extension of indication was also approved by the CHMP this month, recommending use of nivolumab as a monotherapy in locally advanced or metastatic non-squamous NSCLC.

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 EU languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

The opinions adopted by the CHMP at its February 2016 meeting are an intermediary step on nivolumab’s path to patient access. The CHMP opinions will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisations. Once the extensions of indications have been granted, a decision about price and reimbursement will take place at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country.

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

For information, the full indications for nivolumab will be as follows:


Nivolumab as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.


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

Renal Cell Carcinoma

Nivolumab as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.