The FDA approved a subcutaneous injection version of Bristol Myers Squibb nivolumab and hyaluronidase-nvhy for the treatment of several cancers including melanoma, non-small cell lung cancer and renal cell carcinoma.
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.