FDA Approves Opdivo Qvantig for Mesothelioma

The FDA approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) on December 27, 2024, a subcutaneous formulation that delivers the same immunotherapy in under 5 minutes compared to the 30-minute intravenous infusion previously required. This approval includes the mesothelioma indication where nivolumab is used in combination with ipilimumab as first-line treatment.

For mesothelioma patients who may receive nivolumab every 2-4 weeks for extended periods, the time savings and convenience of subcutaneous administration represents a meaningful improvement in treatment experience.

What Changed with This Approval

Administration method: Opdivo Qvantig is injected subcutaneously (under the skin) rather than infused intravenously. The injection takes approximately 3-5 minutes compared to 30 minutes for the IV formulation.

Same active drug: The nivolumab molecule is identical to IV Opdivo. The subcutaneous formulation adds hyaluronidase, an enzyme that helps the drug absorb into the bloodstream from under the skin.

Same dosing schedule: Patients receive Opdivo Qvantig on the same schedule as IV nivolumab, either every 2 weeks (240 mg) or every 4 weeks (480 mg).

Same efficacy: Clinical trials demonstrated equivalent drug exposure and efficacy between subcutaneous and IV formulations.

Clinical Trial Data

The approval was based on the CheckMate-8LX study (NCT05220982), which compared pharmacokinetics and safety between subcutaneous and IV nivolumab:

Pharmacokinetic equivalence: The study demonstrated that subcutaneous nivolumab achieved equivalent blood levels to IV nivolumab across multiple tumor types.

Safety profile: Adverse events were similar between formulations. Injection site reactions occurred in some patients receiving subcutaneous administration, typically mild and manageable.

Patient preference: Studies of subcutaneous immunotherapy formulations generally show patient preference for shorter administration times and the option for less frequent clinic visits.

Implications for Mesothelioma Patients

The nivolumab plus ipilimumab combination (CheckMate 743) is approved as first-line treatment for unresectable pleural mesothelioma. Under this regimen:

• Nivolumab: 360 mg every 3 weeks or 3 mg/kg every 2 weeks
• Ipilimumab: 1 mg/kg every 6 weeks
• Treatment continues until disease progression or unacceptable toxicity

With the Opdivo Qvantig approval, the nivolumab portion of this regimen can now be delivered subcutaneously. This means:

Shorter infusion visits: Overall chair time decreases significantly when nivolumab is given subcutaneously. Ipilimumab still requires IV infusion on its scheduled days.

Potential for home administration: While not yet standard practice, subcutaneous formulations open possibilities for future home-based administration under appropriate supervision.

Reduced burden: For patients traveling long distances to treatment centers, shorter visits reduce fatigue and time away from home.

How Subcutaneous Immunotherapy Works

Hyaluronidase, the added enzyme in Opdivo Qvantig, temporarily breaks down hyaluronan in the tissue under the skin. This allows larger volumes of medication to be absorbed more quickly than would otherwise be possible with subcutaneous injection.

This technology has been used successfully in other cancer treatments, including subcutaneous formulations of rituximab (Rituxan Hycela) and trastuzumab (Herceptin Hylecta), which have been available for several years.

What This Means Practically

Ask your oncologist: If you are currently receiving IV nivolumab or will be starting nivolumab-based treatment, discuss whether Opdivo Qvantig is appropriate for your situation.

Insurance coverage: New formulations may require prior authorization. Your treatment team can help navigate coverage questions.

Same monitoring: Subcutaneous administration does not change the need for regular monitoring of treatment response and side effects.

Combination treatment: When receiving nivolumab plus ipilimumab, you will still need IV access for ipilimumab infusions.

The Broader Trend

The Opdivo Qvantig approval reflects a broader movement toward more convenient immunotherapy delivery:

Patient-centered care: Reducing treatment burden without sacrificing efficacy improves quality of life during cancer treatment.

Healthcare efficiency: Shorter administration times free up infusion center capacity and reduce healthcare costs.

Future developments: Other immunotherapy agents may follow with subcutaneous formulations as manufacturers seek to improve patient experience.

Current Availability

Opdivo Qvantig became available in the United States following the December 2024 approval. Patients interested in transitioning from IV to subcutaneous nivolumab should discuss timing and logistics with their oncology team.

The approval covers all adult indications previously approved for IV Opdivo, including unresectable malignant pleural mesothelioma in combination with ipilimumab.

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• Mesothelioma Immunotherapy
• First-Line Treatment Options
• Managing Immunotherapy Side Effects