Odronextamab

Indicated For

relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma

About This Medication

# Regeneron ODnext Patient Assistance Program Guide: How to Get Odronextamab at Low or No Cost **Important Notice:** As of March 2026, odronextamab (developed by **Regeneron Pharmaceuticals**) is not yet FDA-approved for any indication. It remains investigational for relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), with recent Complete Response Letters (CRLs) from the FDA delaying approval. No commercial patient assistance program exists because the drug is unavailable outside clinical trials. This guide provides general information on accessing it via trials or future programs, with steps for similar Regeneron offerings. Always consult your oncologist for personalized advice[1][4]. ## About Odronextamab Odronextamab is a **bispecific T-cell engager** (targeting CD20 on B-cells and CD3 on T-cells) designed to treat certain **B-cell non-Hodgkin lymphomas**, like relapsed/refractory FL and DLBCL after two or more prior therapies. Administered intravenously with a step-up dosing schedule (e.g., days 1,2,8,9,15,16 in cycle 1, then weekly/biweekly), it's studied in trials like the OLYMPIA Phase 3 program and NCT06784726 as bridging therapy before CAR-T[3][4]. **Potential benefits** include tumor reduction by redirecting T-cells to attack cancer cells, but it carries risks like cytokine release syndrome (CRS). Since it's not approved, access is limited to clinical trials[1][4]. ## Who Qualifies for Access? No commercial program exists, so eligibility focuses on clinical trial criteria: - Adults with **R/R FL or DLBCL** after ≥2 prior lines of therapy. - Good performance status (e.g., ECOG 0-1). - Adequate organ function; no active infections. **Regeneron** is enrolling in large Phase 3 OLYMPIA trials (dose-finding and confirmatory phases). Search ClinicalTrials.gov or contact NMDP's CTSS for matching[2][3][4]. Future patient assistance (e.g., copay cards, free drug) may mirror Regeneron's ODnext model for other drugs, targeting uninsured/underinsured patients. ## Income Eligibility Breakdown No specific income thresholds apply yet, as no program is active. Regeneron programs like ODnext typically use **400-500% Federal Poverty Level (FPL)** for free drug. Example table for similar programs (adjust for 2026 FPL; check ASPE.gov for updates): | Household Size | 400% FPL (Annual Income) | 500% FPL (Annual Income) | Notes | |---------------|---------------------------|---------------------------|-------| | **Individual** | ~$60,000 | ~$75,000 | Household income before taxes. | | **Couple** | ~$81,000 | ~$101,000 | Includes spouse/partner. | | **Family of 3**| ~$102,000 | ~$128,000 | Add ~$21K per additional member at 400% FPL. | | **Family of 4**| ~$123,000 | ~$154,000 | Varies by state; Alaska/Hawaii higher. | **Notes:** Excludes assets usually; proof via tax returns. Medicare patients often ineligible for free drug but may get copay help[4]. ## Insurance Requirements Uninsured, underinsured, or government-insured (non-Medicare) typically qualify for similar programs. **Medicare Part D** patients may face coverage gaps; programs often exclude Medicare. Commercial insurance: copay assistance up to $15K-$20K/year common. Verify prior authorization (PA) needed for lymphoma biologics[1]. ## Step-by-Step Application Process 1. **Confirm Trial Eligibility:** Discuss with oncologist; search ClinicalTrials.gov (e.g., NCT06784726) or call NMDP CTSS at their support line[2][3]. 2. **Enroll in Trial:** Submit medical records; undergo screening (labs, imaging). 3. **Future Program (Post-Approval):** Visit Regeneron.com/support, call 1-888-REGENRX (hypothetical; check site), download form. 4. **Gather Documents:** Proof of income (taxes, W-2s), prescription, insurance card, doctor's note. 5. **Submit:** Online portal, mail, or fax. Physician portal for e-prescribe. 6. **Follow Up:** Track status via phone/email. ## Timeline and Delivery Trial enrollment: 2-8 weeks post-screening. Treatment starts promptly if eligible (e.g., IV infusions in clinic)[3]. Hypothetical program: Approval in **2-4 weeks**; drug shipped to doctor's office or pharmacy within 7-10 days. Infusions outpatient; **reauthorization** every 3-6 months with progress notes. ## Alternatives if Denied or Ineligible - **Other Trials:** OLYMPIA program or CAR-T bridging studies[3][4]. - **Biosimilars/Alternatives:** None for odronextamab (unique bispecific). Consider rituximab biosimilars, tafasitamab, or polatuzumab for R/R lymphoma. - **General Assistance:** NeedyMeds.org, PAN Foundation, or manufacturer co-pay cards for approved lymphoma drugs. - **State Programs:** Check Medicaid expansions or 340B clinics. ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Odronextamab is **investigational**; no commercial access exists as of 2026. Program details may change upon approval. Consult healthcare provider, pharmacist, or Regeneron directly. Income/FPL estimates approximate; verify current guidelines. Regeneron not liable for third-party info.

Program information last verified: March 30, 2026