FDA Approves Nivolumab With Ipilimumab for Renal Cell Carcinoma

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Approval was based on results from the randomized phase 3 CheckMate-214 study.
Approval was based on results from the randomized phase 3 CheckMate-214 study.

The US Food and Drug Administration (FDA) has approved first-line nivolumab plus ipilimumab for patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), according to a press release.1

Approval was based on results from the randomized phase 3 CheckMate-214 study (ClinicalTrials.gov Identifier: NCT02231749), which compared the combination with sunitinib among 847 patients.

The median overall survival (OS) was not reached among the 425 patients receiving nivolumab plus ipilimumab compared with 25.9 months among the 422 patients receiving sunitinib (hazard ratio, 0.63; P < .0001). The overall response rate was 41.6% in the combination arm compared with 26.5% in the sunitinib arm (P < .0001).

The most common adverse events in the immunotherapy arm were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.

Prescribing information for nivolumab and ipilimumab are available on the FDA's website.

Reference

  1. FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; April 16, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm. Accessed April 16, 2018.

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