The US FDA has granted a priority review to Bristol-Myers Squibb's marketing application for Opdivo as a treatment for renal cell carcinoma, a form of kidney cancer.
The PD-1 inhibitor - which has already been approved for melanoma and non-small cell lung cancer - has been filed as a second line therapy for RCC after prior anti-angiogenic therapy with drugs such as, Roche's Avastin (bevacizumab), Pfizer's Sutent (sunitinib) or Bayer's Nexavar (sorafenib).
The FDA has already classed Opdivo a breakthrough therapy in RCC,. The priority review has been granted on the strength of overall survival data from the CheckMate-025 study, which showed that BMS' drug reduced the risk of death by 27% compared to Novartis' Afinitor (everolimus) in this patient population.
RCC is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year, although kidney cancer is less common than both lung cancer and melanoma. Globally, the five-year survival rate for those diagnosed with kidney cancer is 12.1%, in part because most first-line therapies provide a short-term benefit and eventually lose their efficacy.
"There remains a significant unmet medical need for advanced RCC patients who have received prior therapy and are often repeatedly treated with agents that are similar in mechanism," said Michael Giordano, BMS' head of oncology development.
"We will continue to work with urgency to bring Opdivo to patients with this cancer," he added. BMS is also testing Opdivo in combination with its melanoma therapy Yervoy (ipilimumab) - another checkpoint inhibitor - in advanced RCC.
Opdivo has achieved sales of $467m for BMS since launch - $305m of that in the last quarter - ahead of the $352m Merck & Co booked for its rival PD-1 inhibitor Keytruda (pembrolizumab).
Approval in RCC would help BMS pull further away from Merck in the market, as Keytruda is still in early-stage testing for kidney cancer, although there are anecdotal reports that a sizeable hunk of the turnover for Merck's drug is coming from off-label use in RCC.
Down the line, competition could also come from Roche's PD-L1 inhibitor atezolizumab - which is in phase III testing for RCC in combination with Avastin.