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# FDA Accepts sBLA for Odivo/Yeroy Combination
- URL: https://www.fdaweb.com/fda-accepts-sbla-for-odivo-yeroy-combination/
- Published: 2017-12-14T12:00:00.000Z
- Updated: 2026-09-14T23:08:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140354

FDA has accepted a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The submission is based on data from the Phase 3 CheckMate-214 study, which was stopped early based on the recommendation of an independent data monitoring committee following a planned interim analysis of overall survival. The study met the co-primary endpoints of improved overall survival and objective response rate in patients on the combination therapy compared to sunitinib in intermediate- and poor-risk patients. “While the combination demonstrated an improvement in progression-free survival relative to sunitinib, another co-primary endpoint, it did not reach statistical significance,” the company says.

Bristol-Myers Squibb says that adverse events leading to discontinuation were reported in 22% of patients in the combination group, compared with 12% of patients in the sunitinib group. The most common severe adverse events were fatigue (4%), diarrhea (4%), rash (2%), nausea (2%), and, in less than 1% each, pruritus, hypothyroidism, vomiting and hypertension.