On 21 May 2015, the European Medicines 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 (Nivolumab BMS), intended for the treatment of adults with locally-advanced or metastatic squamous non-small cell lung cancer (NSCLC).
The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
Nivolumab will be available as a 10 mg/ml concentrate for solution for infusion. The active substance of Nivolumab BMS is nivolumab, an antineoplastic monoclonal antibody (ATC code L01XC17).
Nivolumab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
The recommendation from CHMP is based on one main randomised trial in patients with advanced squamous NSCLC who had previously failed treatment with chemotherapy. This phase III study randomly assigned 272 patients to receive either nivolumab or docetaxel. The study found that nivolumab improved overall survival compared with docetaxel, median 9.2 months compared with 6.0 months (HR = 0.59; 96.85% CI: 0.43, 0.81; p-value = 0.0002). After 12 months, 42% of patients treated with nivolumab were still alive compared with 24% of patients treated with docetaxel. Nivolumab group had also an improvement in objective response rate compared with docetaxel treated patients (20% versus 8.8%, respectively).
Nivolumab recommendation is also supported by data from an uncontrolled study involving 117 patients with squamous NSCLC who had at least two previous chemotherapy treatments and who were then treated with nivolumab.
A follow-up plan to monitor the safety and efficacy of nivolumab was agreed by the CHMP.
The most common side effects are fatigue, decreased appetite, 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: “Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults”.
It is proposed that nivolumab 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.
The opinion adopted by the CHMP is an intermediary step on nivolumab’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system.