www.fdanews.com/articles/177341-opdivo-lands-another-breakthrough-therapy-designation
Opdivo Lands Another Breakthrough Therapy Designation
July 1, 2016
Bristol-Myers Squibb scored another win for its cancer drug Opdivo, this time picking up breakthrough therapy designation from the FDA for the treatment of metastatic urothelial carcinoma.
The drug already holds breakthrough status for five indications: metastatic squamous cell carcinoma of the head and neck, Hodgkin lymphoma, advanced melanoma, non-squamous non-small cell lung cancer and metastatic renal cell carcinoma.