Tag Archives: opdivoqvantig

Health, Health & Safety

FDA Approves Subcutaneous Opdivo Qvantig for Most Solid Tumor Indications

Leave a comment

The U.S. Food and Drug Administration (FDA) has recently approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous use in treating most adult solid tumor indications previously approved for intravenous Opdivo (nivolumab). This milestone provides a more convenient administration method for cancer patients, enhancing treatment delivery and overall patient experience.

What Is Opdivo Qvantig?

Opdivo Qvantig is a combination therapy that includes:

  • Nivolumab: A PD-1 immune checkpoint inhibitor that works by boosting the body’s immune response against cancer cells.
  • Recombinant Human Hyaluronidase (nvhy): An enzyme that facilitates the dispersion and absorption of nivolumab when administered subcutaneously.

Scope of Approval

This new subcutaneous formulation is approved for:

  1. Monotherapy: Standalone treatment for certain cancers.
  2. Maintenance Therapy: After initial treatment with Opdivo plus Yervoy (ipilimumab).
  3. Combination Therapy: Alongside chemotherapy or cabozantinib in specified cancer types.

The approval extends to most adult solid tumor indications where intravenous Opdivo was previously authorized.

CheckMate-67T Trial: Supporting Data

Study Design

The approval is supported by the CheckMate-67T trial, a phase 3 randomized, open-label study comparing subcutaneous Opdivo Qvantig to intravenous Opdivo.

Key Findings

  1. Noninferiority Achieved:
    • Coprimary End Points:
      • Time-averaged concentration over 28 days.
      • Minimum concentration at a steady state.
    • Subcutaneous Opdivo Qvantig was found to be noninferior to its intravenous counterpart.
  2. Improved Response Rates:
    • Subcutaneous Opdivo Qvantig demonstrated an overall response rate (ORR) of 24%, compared to 18% for intravenous Opdivo.

Benefits of Subcutaneous Administration

  1. Convenience: A quicker delivery method compared to intravenous infusion.
  2. Patient Comfort: Less invasive and potentially more comfortable for cancer patients undergoing regular treatment.
  3. Efficiency: Reduces the time spent in clinical settings, making treatment more accessible.

Industry Perspective

Adam Lenkowsky, executive vice president and chief commercialization officer at Bristol Myers Squibb, emphasized the significance of this approval:

“Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types. With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”

Implications for Patients and Healthcare Providers

This approval is a step forward in enhancing the quality of life for cancer patients by providing a more efficient treatment option. Healthcare providers now have greater flexibility in delivering immunotherapy, which may improve patient adherence and outcomes.