FDA approves new injectable version of Opdivo

The US Food and Drug Administration (FDA) on Friday approved nivolumab and hyaluronidase-nvhy, under the trade name Opdivo Qvantig, from US pharma major Bristol Myers Squibb (NYSE: BMY), for subcutaneous injection across approved adult, solid tumor nivolumab 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, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo Qvantig is not indicated in combination with intravenous ipilimumab.

Like other PD-1 drugs such as Merck & Co's (NYSE: MRK) Keytruda (pembrolizumab), Opdivo was previously available through infusions and patients received it via an intravenous drip in a health office. Standard Opdivo reported global sales of $9 billion in 2023.