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.”
The U.S. approval was based on data from CheckMate -025, an open-label, randomized phase III study which demonstrated a median OS benefit of 25 months (95% CI: 21.7-NE) compared with 19.6 months (95% CI: 17.6-23.1) for everolimus (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]).
FDA previously granted Breakthrough Therapy Designation to Opdivo for advanced RCC patients treated with prior anti-angiogenic therapy, also based on positive results from the CheckMate -025 study.
“This approval of Opdivo represents a major milestone for the kidney cancer community,” said William P. Bro, chief executive officer and patient coordinator, Kidney Cancer Association. “We thank Bristol-Myers Squibb and the FDA for working swiftly to bring this important new treatment option and potential for extended survival to patients.”
