Halozyme And Bristol Myers Squibb Revolutionize Cancer Treatment With Opdivo Qvantig™
FDA approves Opdivo Qvantig™, the first subcutaneous PD-1 inhibitor, with Halozyme’s ENHANZE® technology.
Breaking News
Dec 31, 2024
Simantini Singh Deo

Halozyme Therapeutics, Inc. has announced that Bristol Myers Squibb has received FDA approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy). This Opdivo Qvantig™ is co-formulated with Halozyme's ENHANZE® drug delivery technology. This innovative formulation allows for subcutaneous administration of Opdivo, covering most previously approved indications for adult solid tumours. These include use as a monotherapy, maintenance therapy after Opdivo plus Yervoy® (ipilimumab) combination treatment, or in combination with chemotherapy or cabozantinib. Notably, Opdivo Qvantig is the first and only subcutaneously delivered PD-1 inhibitor.
This new subcutaneous dose delivery option significantly reduces treatment time to 3–5 minutes to administer compared to the 30 minutes required for intravenous (IV) Opdivo. Subcutaneous administration offers added flexibility for patients and healthcare providers, organising preparation steps and reducing overall treatment time.
Dr Helen Torley, president and chief executive officer of Halozyme, said in a statement, "We are pleased Opdivo Qvantig, which is co-formulated with our ENHANZE drug delivery technology, is now FDA-approved as the first and only subcutaneously administered PD-1 inhibitor in the U.S. This approval represents our ninth co-formulated product and is yet another example of how Halozyme's innovative ENHANZE technology is enabling greater flexibility and optionality for patients."
The FDA’s decision is based on data from the Phase 3 CheckMate-67T trial, which compared Opdivo Qvantig, co-formulated with Halozyme’s recombinant human hyaluronidase (rHuPH20), to IV Opdivo in adults with advanced or metastatic clear cell renal cell carcinoma who had prior systemic therapy. The study demonstrated noninferiority for two co-primary endpoints: the time-averaged concentration over 28 days (Cavgd28) and the minimum concentration at steady state (Cminss). The geometric mean ratios (GMR) were 2.10 (90% CI: 2.00-2.20) for Cavgd28 and 1.77 (90% CI: 1.63-1.93) for Cminss, confirming similar pharmacokinetics.
The overall response rate (ORR) was also comparable as a secondary endpoint. In the Opdivo Qvantig group (n=248), the ORR was 24% (95% CI: 19-30), compared to 18% (95% CI: 14-24) in the IV Opdivo group (n=247), as assessed by a Blinded Independent Central Review (BICR). These findings underscore that Opdivo Qvantig maintains efficacy similar to IV Opdivo while offering the benefits of faster, more flexible administration.