FDA approves BMS’s Opdivo for renal cell carcinoma
pharmafile | November 24, 2015 | News story | Research and Development |
The FDA has approved Bristol Myers Squibb’s immunotherapy Opdivo for the treatment of patients with advanced renal cell carcinoma (RCC).
The latest nod marked the fifth approval for Opdivo (nivolumab) across three distinct tumour types, and comes just two months after the FDA granted the treatment Breakthrough Therapy Designation based on the unmet need in the treatment of RCC.
Opdivo is the first PD-1 inhibitor to deliver significant overall survival (OS) in patients with advanced RCC (kidney cancer) who have received prior anti-angiogenic therapy.
The FDA gave the green light based on results of the Phase III CheckMate -025 trial, where patients treated with Opdivo achieved a median OS of 25 months, compared with 19.6 months for Novartis’ Afinitor (everolimus)- the current standard of care: a 5.4 month survival benefit.
Additionally, 21.5 percent of patients treated with Opdivo saw complete or partial shrinkage of their tumours, for an average of 23 months, compared to 3.9 percent of Afinitor patients, whose tumour shrinkage lasted an average of 13.7 months.
While the treatment landscape for RCC has improved over the last decade with the launch of Afinitor in 2009 and other drugs, Novartis says patients are in need of new treatment options that demonstrate longer-term effects and overall survival benefits.
Francis Cuss, executive vice president and chief scientific officer at Bristol-Myers Squibb, comments: “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 renal cell carcinoma who have received prior anti-angiogenic therapy.
“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.”
While the Kidney Cancer Association welcomed the approval, with CEO William Bro calling it a “major milestone”, patients treated with the therapy must be prepared for potential side effects including immune-mediated pneumonitis, colitis, hepatitis and acute kidney injury, in addition to nausea, breathing difficulties and joint pain.
The safety profile of Opdivo in CheckMate -025 was however shown to be consistent with prior studies.
Joel Levy
