The US Food and Drug Administration (FDA) has approved a new formulation of nivolumab, called Opdivo Qvantig, for the treatment of solid tumors through subcutaneous injection. This approval applies to five adult solid tumor indications: renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and urothelial carcinoma.
The FDA granted this approval based on data from the phase 3 CHECKMATE-67T trial, which showed that subcutaneous nivolumab was as effective as intravenous administration in patients with advanced or metastatic clear cell renal cell carcinoma. In fact, the overall response rate for those treated with subcutaneous nivolumab was higher than those treated with intravenous nivolumab.
The safety profiles of both subcutaneous and intravenous nivolumab are similar, but subcutaneous Opdivo Qvantig has a more favorable side effect profile. The most common adverse effects reported in patients receiving subcutaneous nivolumab include fatigue, musculoskeletal pain, pruritus, rash, and cough.
This approval brings the total number of approved indications for nivolumab to six, following its initial approval as an intravenous medication. As a result, healthcare professionals now have more options for treating patients with advanced solid tumors.
Source: https://www.oncnursingnews.com/view/fda-oks-subcutaneous-nivolumab-in-advanced-metastatic-solid-tumors