Opdivo also known as nivolumab has been extended as treatment for non-squamous non-small cell lung cancer by the U.S. Food and Drug Administration.
The decision was based on evidence from an international, randomised open-label study comparing the safety and effectiveness of Opdivo with docetaxel in 582 patients with progressive NSCLC during or after treatment with platinum-based chemotherapy and appropriate biologic therapy.
Patients treated with Opdivo were observed to live longer, with average overall survival of 12.2 months compared with 9.4 months in patients treated with docetaxel. Additionally more patients in the Opdivo treated group compared with the docetaxel treated group (19% vs. 12%) experienced complete or partial shrinkage of their tumors lasting an average of 17 months and 6 months respectively.
Fatigue, musculoskeletal pain, decreased appetite; cough and constipation were mentioned as major adverse events of Opdivo.
Further details on the press release can be read here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm466413.htm