Locally advanced or metastatic squamous non-small cell lung cancer: positive CHMP opinion for Nivolumab BMS
The CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nivolumab BMS, intended for the treatment of adults with locally advanced or metastatic squamous non-small cell lung cancer ( NSCLC ).
Nivolumab BMS 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.
Nivolumab BMS potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
The benefits with Nivolumab BMS are an increase in overall survival over Docetaxel ( HR=0.59; 96.85% CI: 0.43, 0.81; p-value = 0.0002 ) and an improvement in objective response rate compared with Docetaxel ( 20% versus 8.8%, respectively ) in patients with locally advanced or metastatic squamous NSCLC who received prior chemotherapy.
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. ( Xagena )
Source: European Medicines Agency ( EMA ), 2015