20 August 2021 - On 19 August 2021, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.
This is the first FDA approval for adjuvant treatment of patients with high risk urothelial carcinoma.
The results supporting this approval also supported the conversion of nivolumab’s accelerated approval for advanced/metastatic urothelial carcinoma to a regular approval.