The U. S. Food and Drug Administration has granted approval to nivolumab for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Nivolumab was previously approved in 2014 for the treatment of previously treated unresectable or metastatic melanoma. 

Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumour immune response.

Approval was based on superior overall survival (OS) for patients who were randomly allocated to either nivolumab or docetaxel in an open-label, multicentre, multinational randomised trial in patients with metastatic squamous NSCLC who had experienced disease progression during or after one prior platinum-based chemotherapy regimen.

Patients received nivolumab (n=135), 3 mg/kg intravenously every 2 weeks, or docetaxel (n=137) 75 mg/m2 intravenously every 3 weeks. The major efficacy outcome was OS. 

Nivolumab demonstrated a statistically significant improvement in OS as compared with docetaxel at the protocol pre-specified interim analysis.

Approval was supported by a single-arm, multinational, multicentre trial in patients with metastatic squamous NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen.

The most common adverse reactions among the 117 patients receiving nivolumab in the above single-arm trial were fatigue, dyspnea, musculoskeletal pain, decreased appetite, and cough. The most frequent grade 3 and 4 adverse drug reactions observed in at least 5% of patients treated with nivolumab were dyspnea, fatigue, and musculoskeletal pain.

Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, nephritis/renal dysfunction, hypothyroidism, and hyperthyroidism.

The recommended dose of nivolumab is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.

Source: US Food and Drug Administration