Bristol-Myers Squibb Company announced that FDA has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. This approval expands Opdivo's indication for previously treated squamous NSCLC to include the population of patients with nonsquamous NSCLC.

Indication: For the treatment of patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.

Serious Adverse Reactions: The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pulmonary embolism, dyspnea, pleural effusion, and respiratory failure.

Common Adverse Reactions: The most common adverse reactions (≥20%) reported were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%), and constipation (23%).

Citation: Bristol-Myers Squibb’s Opdivo (nivolumab) receives expanded FDA approval in previously-treated metastatic non-small cell lung cancer (NSCLC), offering improved survival to more patients. [news release]. Princeton, NJ: Bristol-Myers Squibb; October 9, 2015. http://news.bms.com/press-release/bristol-myers-squibbs-opdivo-nivolumab-receives-expanded-fda-approval-previously-treat. Accessed October 16, 2015.