Regulatory Affairs

BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC

PBR Staff Writer Published 17 April 2018

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.

The immuno-oncology combination Opdivo (10mg/mL) and Yervoy (5mg/mL) has been indicated to be intravenously injected in patients with intermediate or poor-risk, advanced RCC, who were previously untreated for their condition.

Its approval is based on the results from a phase 3 trial called CheckMate -214, in which the combination significantly increased the overall survival (OS) in such RCC patients, in comparison to sunitinib, a current standard of care.

Compared to sunitinib, the Opdivo + low-dose Yervoy combination showed a survival benefit irrespective of PD-L1 expression while producing higher objective response rates, including more complete responses in the phase 3 trial.

Further, the combination had produced lesser overall Grade 3 and 4 adverse reactions in the late-stage trial than what were observed in the sunitinib arm.

BMS US commercial head Johanna Mercier said: “Our goal is to provide cancer patients with medicines that have the potential to extend their lives. As the first treatment option to increase overall survival for subgroups of patients with advanced RCC compared to sunitinib, the Opdivo plus low-dose Yervoy combination helps deliver on that promise.

“This approval demonstrates our commitment to bringing Immuno-Oncology treatments that may improve outcomes to a broader range of RCC patients.”

BMS said that the recommended dosing for the Opdivo+Yervoy combination is Opdivo 3mg/kg followed by Yervoy 1mg/kg, each intravenously injected over 30 minutes on the same day, every three weeks for four doses.

After four doses of the combination are over, Opdivo should be injected intravenously 240mg every two weeks or 480mg every four weeks over 30 minutes until disease progression or unacceptable toxicity, said BMS.

In another development, BMS reported that the Opdivo+Yervoy regimen succeeded in reducing the risk of progression or death by 42% in first-line lung cancer patients with high tumor mutational burden, in comparison to chemotherapy in the phase 3 CheckMate -227 trial.

In 2015, the FDA had approved the Opdivo+Yervoy combination for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Image: Bristol-Myers Squibb site at Reeds Lane, Moreton, Wirral, England. Photo: courtesy of Rept0n1x/