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The Cancer Letter Inc.
PO Box 9905
Washington
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: Dec 24, 2015
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FDA Approves Opdivo Injection for Renal Cell Carcinoma Patients 

 

FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

In the CheckMate -025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis.

In the study, the safety profile was consistent with prior Opdivo studies.

“This is the fifth approval for Opdivo across three distinct tumor types. This latest approval reflects our commitment to delivering on our promise to provide cancer patients with a potential for long-term survival,” said Francis Cuss, executive vice president and chief scientific officer at Bristol-Myers Squibb, Opdivo’s sponsor. “We believe our pioneering approach to Immuno-Oncology is driving change in how cancer may be treated.”



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