The approval covers both monotherapy and combination therapy options, including use of chemotherapy and combination therapy options including use with chemotherapy or cabozantinib, according to a Dec. 27 news release from the agency.
The approval is based on results from a randomized, open-label trial in 495 patients with advanced or metastatic clear cell renal cell carcinoma who received either subcutaneous nivolumab and hyaluronidase-nvhy or intravenous nivolumab.
The subcutaneous version showed a 24% overall response rate compared to 18% for the intravenous form.
The new injectable form offers more flexible dosing options, administered every 2 to 4 weeks depending on the treatment regimen.
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