Posted by Michael Wonder on 27 Dec 2024
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
27 December 2024 - Today, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The approval includes indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, oesophageal carcinoma, gastric cancer, gastro-oesophageal junction cancer, and oesophageal adenocarcinoma.
