FDA approves Opdivo as subcutaneous injection
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Key takeaways:
- Opdivo was previously only available intravenously.
- The approval comes after CHECKMATE-67T study results.
- Opdivo and Opdivo Qvantig showed similar safety profiles.
The FDA has approved nivolumab and hyaluronidase-nvhy for subcutaneous injection in adults with solid tumors in which nivolumab is indicated, according to a press release.
Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) is the subcutaneous form of nivolumab (Opdivo, Bristol Myers Squibb), an anti-PD-1 antibody that was previously only available through infusions via intravenous drip.
The release states the drug has been approved for subcutaneous injection in the treatment of 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.
The approval was based on the multicenter, randomized, open-label CHECKMATE-67T trial, according to the FDA release. The trial included 495 patients with advanced or metastatic clear cell renal cell carcinoma who underwent no more than two prior systemic treatments and were randomly assigned to receive either subcutaneous nivolumab and hyaluronidase-nvhy or intravenous nivolumab.
CHECKMATE-67T showed that subcutaneous nivolumab and hyaluronidase-nvhy had a similar safety profile as intravenous nivolumab. The overall response rate was 24% (95% CI, 19-30) for subcutaneous nivolumab and hyaluronidase-nvhy and 18% (95% CI, 12-24) for intravenous nivolumab. The most reported adverse reactions included fatigue, musculoskeletal pain, pruritus, rash and cough.
The release states that the recommended dosage of subcutaneous nivolumab and hyaluronidase-nvhy depends on the indication. It is either 600 mg nivolumab and 10,000 units hyaluronidase every 2 weeks; 900 mg nivolumab and 15,000 units of hyaluronidase every 3 weeks; or 1,200 mg nivolumab and 20,000 units hyaluronidase every 4 weeks.
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