June verdict expected for BMS' Opdivo in lung cancer
This article was originally published in Scrip
The FDA has granted a priority review to Bristol-Myers Squibb's application for Opdivo (nivolumab) as a treatment for patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy.
The FDA is expected to make a decision by 22 June, the drug's Prescription Drug User Fee Act (PDUFA) action date.
But if things go as smoothly as the company's application in advanced melanoma – which won approval in December 2014 three months before its PDUFA date – BMS could be looking at another early decision for the drug in NSCLC (scripintelligence.com, 23 December 2014).
BMS is hoping to be the first company with an immuno-oncology agent on the US market to treat advanced squamous NSCLC.
Opdivo is in a race for approval in the NSCLC indication with Merck's Keytruda (pembrolizumab), which also gained approval last year in melanoma (scripintelligence.com, 4 September 2014).
BMS said its application was based on its single arm, open-label CheckMate -063 Phase II study, which was designed to assess advanced squamous NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy.
In January, BMS revealed its Phase III CheckMate-017 study of Opdivo in previously treated patients with advanced, squamous cell NSCLC was stopped early because the trial met its endpoint, demonstrating superior overall survival versus docetaxel (scripintelligence.com, 12 January 2015).