The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers Squibb (BMS; NYSE: BMY) for a subcutaneous formulation of its anti-PD-1 therapy Opdivo (nivolumab). The new formulation utilizes Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) and aims to cover all previously approved indications for the drug. This development could significantly reduce administration times to under 5 minutes, compared to the 30 to 60 minutes required for the intravenous infusion.
The submission is supported by positive Phase III data, which demonstrated non-inferiority in serum concentration and objective response rate (ORR) in patients with clear cell renal cell carcinoma (ccRCC), as well as a safety profile consistent with that of the intravenous formulation.
The FDA anticipates completing the review process in the next calendar year.- Flcube.com
