Food and Drug Administration (FDA) gave a “yes” for a combination therapy of nivolumab and ipilimumab to treat the immediate risk of untreated advanced renal cell carcinoma (RCC). The decision was granted by FDA via priority review and breakthrough therapy session. This approval was based on an open-label, random trial (NCT02231749) which involved patients who did not receive any treatment for advanced RCC.
Patients were placed on nivolumab (3 mg/kg) in combination with ipilimumab (1 mg/kg) every 3 weeks for 4 doses followed by either nivolumab monotherapy (3 mg/kg) every 2 weeks, or sunitinib 50 mg daily for 4 weeks followed by 2 weeks off each cycle. Effectiveness was estimated in poor-risk to intermediate patients (n=847). Trial presented noteworthy advances in objective response rate (ORR) and overall survival (OS) of those patients placed on the combination (n=425) versus the…
