The FDA granted priority review to a supplemental biologics license application that seeks approval of nivolumab plus ipilimumab for the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma, according to the agents’ manufacturer.
The agency previously granted breakthrough therapy designation for the combination of nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 checkpoint inhibitor — and ipilimumab (Yervoy, Bristol-Myers Squibb), an anti-CTLA-4 antibody.
The FDA is expected to make a decision on the biologics license application for by April 16.
“We hope to provide treatment options to patients with advanced forms of renal cell carcinoma,” Murdo Gordon, executive vice president and chief commercial officer at Bristol-Myers Squibb, said in a company-issued press release. “Breakthrough therapy designation and [this] filing acceptance for the Opdivo-plus-Yervoy combination are an important step in our ongoing efforts to advance therapies to address a high unmet need in first-line treatment of kidney cancer in intermediate- and poor-risk patients.”
The FDA based the priority review on results from the randomized phase 3 CheckMate -214 study, which compared nivolumab plus ipilimumab with sunitinib monotherapy for patients with previously untreated advanced or metastatic renal cell carcinoma.
As HemOnc Today previously reported, an independent data monitoring committee recommended the trial stop early after a planned interim analysis showed the nivolumab-ipilimumab combination improved OS and objective response rate, the study’s two coprimary endpoints.
A higher percentage of patients assigned nivolumab-ipilimumab than sunitinib discontinued treatment due to adverse events (22% vs. 12%).
The most common grade 3 or grade 4 adverse events reported in the combination group were fatigue (4%), diarrhea (4%), rash (2%) and nausea (2%).
Seven treatment-related deaths occurred in the combination group and four occurred in the sunitinib group.
The nivolumab-ipilimumab combination already is approved in the United States for treatment of patients with unresectable or metastatic melanoma.