This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2017
  • /
  • 06
  • /
  • European Commission approves Opdivo(nivolumab) for...
Drug news

European Commission approves Opdivo(nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma .- BMS

Read time: 1 mins
Last updated:26th Jun 2017
Published:4th Jun 2017
Source: Pharmawand

Bristol-Myers Squibb Company announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. This decision makes Opdivo the first Immuno-Oncology agent approved in the European Union for the treatment of patients with this common type of bladder cancer.

The approval was based on results from CheckMate -275, a Phase II, open-label, single-arm, multicenter study evaluating Opdivo in patients with locally advanced or mUC who have disease progression during or following treatment with a platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In this study, 270 patients received Opdivo 3 mg/kg administered intravenously every two weeks until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate (ORR). Secondary endpoints included progression free survival (PFS) and overall survival (OS). In the trial, 20.0% (95% CI: 15.4, 25.3; 54/270) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 3.0% (8/270) and the percentage of patients with a partial response was 17% (46/270).

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.