25 April 2016 - Bristol-Myers Squibb Company announced today that the FDA has granted breakthrough therapy designation to Opdivo for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy.

The breakthrough therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.

This is the fifth breakthrough therapy designation granted for Opdivo by the FDA, with previous breakthrough therapy designation indications including patients with Hodgkin's lymphoma after failure of autologous stem cell transplant and brentuximab, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and advanced or metastatic renal cell carcinoma.

For more details, go to: http://news.bms.com/press-release/bms/bristol-myers-squibbs-opdivo-nivolumab-receives-breakthrough-therapy-designation-u