03:44 PM EST, 12/27/2024 (MT Newswires) -- Bristol-Myers Squibb's ( BMY ) Opdivo Qvantig, a subcutaneous injection of nivolumab and hyaluronidase-nvhy, was approved by the US Food and Drug Administration on Friday for the treatment of solid tumors in adult patients.
The treatment is cleared as monotherapy, monotherapy maintenance after a combination treatment of Opdivo plus Yervoy, or in combination with chemotherapy or cabozantinib, the health regulator said.
Approved dosing includes 600 milligrams nivolumab plus 10,000 units hyaluronidase every two weeks; 900 milligrams nivolumab with 15,000 units hyaluronidase every three weeks; and 1,200 milligrams nivolumab plus 20,000 units hyaluronidase every four weeks, according to the FDA.
The approval is based on results from Checkmate-67T study that showed a similar safety profile between intravenous nivolumab and Opdivo Qvantig, the regulator added.
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