FDA Approves Opdivo for Treatment of Patients with Metastatic Squamous NSCLC

FDA Approves Opdivo for Treatment of Patients with Metastatic Squamous NSCLC

lung cancer mRNAsThe U. S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with a diagnosis of metastatic squamous non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Last December 2014 the FDA approved Opdivo for unresectable or metastatic melanoma.

Opdivo is a programmed death receptor-1 (PD-1) blocking antibody that inhibits receptor-ligand interactions, blocking PD-1 pathway-mediated inhibition of anti-tumoral immune responses.

The approval was the result of a superior overall survival (OS) rate obtained from a recent open-label, multinational, multi-center randomized clinical trial in patients with NSCLS who experienced disease progression during or after one prior platinum-based chemotherapy regimen. Patients were allocated to either receive nivolumab (n=135) with a dose of 3 mg/kg as an intravenous infusion every 2 weeks or docetaxel (n=137) with a dose of 75 mg/m2 as an intravenous infusion every 3 weeks. Protocol pre-specified interim analysis results showed that Nivolumab (median of 9,2 months) significantly improved OS compared to docetaxel (median of 6 months).

In terms of adverse effects, which occurred in 117 patients under nivolumab the most common were dyspnea, fatigue, decreased appetite, cough and musculoskeletal pain. The most common grade 3 and 4 adverse events seen in at least 5% of patients that received nivolumab were dyspnea, musculoskeletal pain and fatigue. Moreover, immune-mediated adverse events included colitis, pneumonitis, nephritis/renal dysfunction, hypothyroidism, hepatitis, and hyperthyroidism.

“With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,” said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb in a recent news release. “As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.”