FDA OKs Treatment Combo for Advanced Renal Cell Carcinoma

Officials with the FDA have approved nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co) as a combination treatment for intermediate or poor risk, previously untreated advanced renal cell carcinoma, according to a press release.

The approvals are based on the clinical trial CheckMate 214, which investigated the combination therapy in patients with previously untreated advanced RCC. In the trial, patients received 4 cycles of nivolumab plus low-dose ipilimumab combination, followed by nivolumab maintenance therapy. In the combination arm of the trial, 79% of patients received all 4 doses of the combination and went on to the nivolumab monotherapy phase.

Nivolumab plus low-dose ipilimumab combination is the first and only treatment to show significantly superior survival compared with sunitinib in intermediate- and poor-risk advanced RCC, including a survival benefit regardless of PD-L1 expression, according to the press release.

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