Opdivo Granted Breakthrough Therapy Designation for New Indication

The FDA has granted breakthrough therapy designation to nivolumb (Opdivo) as a potential treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based therapy.

The FDA’s decision to give the designation was based on data from a phase 3, open-label, randomized trial that evaluated Opdivo in comparison with the investigator’s choice of therapy in patients with SCCHN with tumor progression within 6 months of platinum therapies.

The trial concluded in January 2016 after the independent Data Monitoring Committee decided that the study met its primary endpoint of overall survival.

“The breakthrough therapy designation for Opdivo in advanced squamous cell carcinoma of the head and neck underscores the immediate need for new treatment approaches for this devastating disease and reflects our commitment to advancing immuno-oncology research with the goal of addressing hard-to-treat cancers and changing survival expectations for patients,” said Jean Viallet, global clinical research lead of oncology at Bristol-Myers Squibb, in a press release.

The most common adverse reactions cited in patients using Bristol-Myers Squibb’s Opdivo for other indications include fatigue, diarrhea, rash, nausea, colitis, and pyrexia.