Fianlimab

Indicated For

Advanced melanoma, advanced cutaneous squamous cell carcinoma

About This Medication

# Regeneron Patient Assistance Program Guide: How to Get Fianlimab at Low or No Cost Fianlimab is an investigational immunotherapy drug from Regeneron Pharmaceuticals, primarily studied in combination with cemiplimab for treating advanced or high-risk melanoma. Since it is not yet FDA-approved and no specific patient assistance program (PAP) details are available, this guide outlines general steps for accessing Regeneron's support, clinical trials, and financial aid options for eligible patients facing insurance or cost barriers.[1][2] ## About Fianlimab **Fianlimab** (REGN3767) is a human anti-LAG-3 monoclonal antibody, an immune checkpoint inhibitor that blocks the LAG-3 protein to enhance the immune system's ability to fight cancer cells. It is typically combined with **cemiplimab** (Libtayo®), a PD-1 inhibitor, showing promising results in clinical trials for melanoma. In phase I trials, the combination achieved a 57% response rate in PD-1-naïve advanced melanoma patients, with 25% complete responses, and 46% responses in previously treated patients.[2][6] Ongoing phase II/III trials (e.g., NCT06190951) test it as neoadjuvant/adjuvant therapy for resectable stage III/IV melanoma, dosed every 3 weeks.[3][5] Common side effects include adrenal insufficiency, fatigue, and immune-related issues—discuss risks with your doctor.[2] Fianlimab targets high-risk melanoma patients with good performance status (ECOG 0-1) and no uncontrolled infections or recent immunosuppressive therapy.[3][4] ## Who Qualifies for Assistance? Regeneron offers patient support for eligible patients with insurance gaps or financial hardship, though specific fianlimab PAP details are limited as it's investigational.[1] General Regeneron programs help uninsured, underinsured, or low-income patients get medications at low/no cost. Qualification often includes: - U.S. residency. - Valid prescription for a Regeneron product (fianlimab access may route through trials). - Household income typically up to 400-500% of Federal Poverty Level (FPL), adjusted yearly. Since fianlimab lacks a commercial PAP, priority access is via clinical trials for eligible melanoma patients.[2][3] ## Income Eligibility Breakdown Regeneron PAPs generally use FPL guidelines (2026 estimates; verify current via Regeneron). Here's a sample table for a household of 1-4 (multiply by 1.33 for Hawaii/Alaska): | Household Size | 400% FPL (Annual Income) | 500% FPL (Annual Income) | |----------------|---------------------------|---------------------------| | 1 | $60,240 | $75,300 | | 2 | $81,760 | $102,200 | | 3 | $103,280 | $129,100 | | 4 | $124,800 | $156,000 | Higher incomes may qualify if insurance denies coverage. Medicare patients often ineligible for free drug but may get copay help.[1] ## Insurance Requirements - **Commercial insurance**: Program bridges deductibles/copays if income qualifies. - **Medicare/Medicaid**: Typically ineligible for free drug; explore copay assistance or trials. - **Uninsured**: Primary candidates for full support. Provide proof of insurance denial or high costs. Fianlimab's trial access bypasses insurance for participants.[1][3] ## Step-by-Step Application Process 1. **Consult your doctor**: Confirm fianlimab suitability; get prescription. Ask about trials (clinicaltrials.gov).[2][3] 2. **Check eligibility**: Use Regeneron's portal or call 1-888-REGENRX (general support line; fianlimab-specific TBA).[1] 3. **Gather documents**: Prescription, income proof (tax returns/W-2s), insurance card/denial letter, ID.[1] 4. **Apply online/phone**: Visit regeneron.com/support or call. Download forms if available.[1] 5. **Submit**: Mail/fax/upload. Expect verification call. 6. **Approval**: If approved, drug ships to doctor/pharmacy. For trials: Search NCT06190951; contact study sites (e.g., MD Anderson).[3][5] ## Timeline and Delivery - **Processing**: 1-2 weeks for PAPs; trials vary (screening 2-4 weeks).[1] - **Delivery**: Free shipping to prescriber's office or home. Infusions at clinic. - **Supply**: 1-3 months initially; auto-refill option. ## Alternatives if Denied - **Clinical trials**: Enroll in fianlimab studies (free drug/monitoring).[2][3][7] - **Other PAPs**: PAN Foundation, NeedyMeds for melanoma/immunotherapy. - **Manufacturer copay cards**: Regeneron options for insured. - **Financial aid**: CancerCare, state programs. - **Biosimilars**: None for fianlimab (novel); consider approved LAG-3/PD-1 combos like nivolumab+relatlimab.[6] ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Fianlimab is investigational; availability limited to trials. Eligibility/program details change—contact Regeneron directly. Consult healthcare provider for personalized guidance. Data as of available sources; verify at rxassist.org or regeneron.com.[1][2]

Program information last verified: March 30, 2026