FDA has accepted Bristol Myers Squibb’s Biologics License Application (BLA) for a new formulation of Opdivo® (nivolumab), co-developed with Halozyme and containing their proprietary recombinant human hyaluronidase (rHuPH20), which has the potential to significantly improve the treatment experience for patients with solid tumors.
This approval was supported by promising results from the CheckMate -67T study, offering hope for solid tumor patients.
Gina Fusaro, VP, global program lead at Bristol Myers Squibb, highlighted the promising potential of subcutaneous nivolumab.
She emphasized that nivolumab was approved for many different types of cancer, and the company’s continued investment in patient-centric research remains a priority.
If approved, nivolumab would offer patients and doctors a new option, delivering the same benefits as IV Opdivo but with the convenience of a quicker injection, taking only three-to-five minutes instead of a 30-to-60-minute infusion.
These findings of nivolumab in treating solid tumors were presented at the prestigious ASCO 2024 Genitourinary Cancers Symposium.
Source: U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)
