BMS receives FDA approval for Opdivo, the only treatment to deliver significant overall survival in advanced renal cell carcinoma

Fifth approval for Opdivo in 12 months.

“This is the fifth approval for Opdivo across three distinct tumour 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 BMS. “We believe our pioneering approach to immuno-oncology is driving change in how cancer may be treated.”

The US 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]). This is the first time an immune checkpoint inhibitor has delivered a significant survival benefit in this patient population. On 16 September 2015, the FDA 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, reinforcing the unmet need in the treatment of RCC.

“As an immuno-oncology agent that works directly with the body’s immune system, Opdivo offers a new approach for physicians to use when treating patients with advanced RCC who have received prior anti-angiogenic therapy,” continued Cuss. “For the first time, these patients have a PD-1 inhibitor treatment option, which has the potential to provide an unprecedented survival advantage compared to a standard of care.”