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FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
On January 22, 2021, the Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC). This application was granted fast track review, and both the nivolumab and cabozantinib applications were granted priority review.
This approval was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9ER trial in patients with previously untreated advanced RCC. Patients were randomized to receive nivolumab plus cabozantinib (n=323) or nivolumab plus sunitinib (n=328).
The median progression-free survival (per blinded independent central review(BICR))was 16.6 months in the nivolumab plus cabozantinib arm versus 8.3 months in patients receiving nivolumab plus sunitinib. Confirmed overall response rate per BICR was 55.7% in the nivolumab plus cabozantinib arm versus 27.1% in the sunitinib arm. Median OS was not reached in either arm.
The most common (≥20%) adverse events associated with nivolumab plus cabozanitinib use were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.—Kaitlyn Manasterski
Source: US Food and Drug Administration. FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma. Updated January 22, 2021. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-plus-cabozantinib-advanced-renal-cell-carcinoma. Accessed January 22, 2021.
