Fianlimab

Indicated For

Advanced melanoma, metastatic melanoma, unresectable melanoma

About This Medication

# Regeneron Patient Assistance Program Guide: How to Get Fianlimab at Low or No Cost Fianlimab (REGN3767) is an **experimental immunotherapy drug** developed by **Regeneron Pharmaceuticals** for treating advanced melanoma and other cancers. As it is not yet FDA-approved and remains in clinical trials, there is no standard commercial patient assistance program (PAP) specifically for fianlimab. However, Regeneron offers general support options that may apply.[1][2][3][5] ## About Fianlimab Fianlimab is a fully human monoclonal antibody that targets the **LAG-3 immune checkpoint receptor** on T cells, helping the immune system better fight cancer cells. It is primarily studied in combination with **cemiplimab (Libtayo®)**, a PD-1 inhibitor already approved for certain cancers.[1][2][4][7] Key facts: - **Primary use**: High-risk, resectable stage 3 or 4 melanoma (given before and potentially after surgery).[2][4] - **Development stage**: Phase 2/3 clinical trials (e.g., NCT06190951); also Phase 1 for lymphoma and other solid tumors.[1][4][6] - **Early results**: In advanced melanoma patients new to PD-1 therapy, the combo showed >60% response rates; safety similar to single-agent PD-1 inhibitors.[2][7] - **Administration**: Intravenous infusion.[6] Since fianlimab is investigational, access comes through **clinical trials** or Regeneron's **Managed Access Program** for serious conditions when trials or alternatives aren't available.[5] ## Who Qualifies for Assistance? Regeneron does not list a dedicated PAP for fianlimab, unlike programs for approved drugs like EYLEA (Eylea-4U), Libtayo (Libtayo Surround), or Praluent (MyPRALUENT).[3] Eligibility focuses on: - **U.S. residents** (including territories) with serious/life-threatening conditions.[5] - **Financial need**: General PAPs target those unable to afford medications; income thresholds vary but often 400-500% of Federal Poverty Level (FPL).[3] - **Clinical trial eligibility**: Must meet trial criteria (e.g., high-risk melanoma, no prior certain treatments).[2][4] **Income Eligibility Breakdown** (based on Regeneron general PAP patterns; confirm for your case): | Household Size | Annual Income Limit (400% FPL, 2026 est.) | Notes | |---------------|-------------------------------------------|-------| | 1 | $60,240 | May adjust higher for experimental drugs | | 2 | $81,760 | Excludes certain assets | | 3 | $103,280 | Proof required | | 4 | $124,800 | Add ~$21,520 per additional person | | 5 | $146,320 | [3][5] | ## Insurance Requirements - **Commercial insurance**: Regeneron PAPs often require denial or high copays first; investigational drugs typically aren't covered.[3][5] - **Medicare/Medicaid**: Generally ineligible for manufacturer PAPs; use Extra Help or state programs instead.[3] - **Uninsured/underinsured**: Primary qualifiers for free medicine via foundations or managed access.[5] ## Step-by-Step Application Process 1. **Confirm eligibility**: Discuss with your oncologist if you qualify for trials (clinicaltrials.gov, NCT06190951) or Managed Access.[1][4][5] 2. **Contact Regeneron**: Call 1-877-542-8296 (adverse events line, but start for access inquiries) or visit regeneron.com for support programs.[5][8] 3. **Apply for general PAP**: Use rxassist.org for Regeneron listings; submit via phone/online for similar drugs as template.[3] 4. **Gather documents**: See below. 5. **Physician involvement**: Doctor submits prescription and medical justification. 6. **Third-party foundations**: Regeneron donates to foundations like Patient Access Network (PAN) for copay help.[5] ## Required Documents Typical for Regeneron programs (adapt for fianlimab): - Proof of income (tax returns, pay stubs). - Proof of residency (U.S. ID). - Prescription and medical records. - Insurance denial letter (if insured). - Physician's application form.[3] ## Timeline and Delivery - **Processing**: 2-4 weeks for PAPs; faster for compassionate use (days to weeks).[3][5] - **Delivery**: Free medication shipped to doctor's office or home via specialty pharmacy.[3] - **Trial enrollment**: Varies by site; treatment starts post-screening (1-4 weeks).[4] ## If Denied or Alternatives - **Appeal**: Resubmit with more docs or physician letter. - **Clinical trials**: Search clinicaltrials.gov for fianlimab (free treatment).[1][2][4] - **Financial aid**: PAN Foundation, HealthWell Foundation, or CancerCare. - **Biosimilars**: None for fianlimab (experimental); consider other LAG-3/PD-1 combos if approved.[6] - **Compassionate use**: Regeneron Managed Access for non-trial access.[5] ## Important Disclaimer This guide is for informational purposes only and not medical/financial advice. Fianlimab is **not FDA-approved**; availability limited to trials or expanded access. Consult your healthcare provider. Program details change; verify with Regeneron (regeneron.com) or 1-877-542-8296. Income tables estimated from general PAP standards.[1][3][5][8] (Word count: 912)

Program information last verified: March 30, 2026