Bemarituzumab

Indicated For

FGFR2b-positive gastric cancer, gastroesophageal junction cancer

About This Medication

# Amgen Support Program Patient Guide: How to Get Bemarituzumab at Low or No Cost Bemarituzumab is an investigational targeted therapy from **Amgen** for **FGFR2b-positive first-line gastric or gastroesophageal junction (G/GEJ) cancer**, showing promising results in improving overall survival when combined with chemotherapy like mFOLFOX6.[1][5] As of March 2026, this drug is not yet FDA-approved, so no established patient assistance program exists—**this guide provides general guidance on accessing Amgen support and next steps while you await approval.** Contact Amgen directly for the latest information on potential expanded access or future programs. ## About Bemarituzumab Bemarituzumab is a first-in-class investigational monoclonal antibody that targets **fibroblast growth factor receptor 2b (FGFR2b)**, a protein overexpressed in certain gastric and GEJ cancers.[2][7] In the Phase 3 **FORTITUDE-101 trial**, bemarituzumab plus mFOLFOX6 (a chemotherapy regimen including fluorouracil, leucovorin, and oxaliplatin) met its primary endpoint of **statistically significant overall survival (OS) improvement** compared to chemotherapy alone in patients with FGFR2b overexpression (defined as 2+ or 3+ staining in ≥10% of tumor cells via IHC testing).[1][5][7] Key trial highlights: - Conducted across 300 sites in 37 countries with 547 patients.[5] - Common side effects (>25%) include **reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye**—ocular events were more frequent and severe with bemarituzumab.[1][5][7] - Earlier Phase 2 FIGHT trial showed median OS of 19.2 months vs. 13.5 months with chemotherapy alone.[9] Detailed results are expected at upcoming medical meetings, with another Phase 3 trial (bemarituzumab + chemo + nivolumab) readout anticipated in late 2025.[1][5] If approved, it could become a frontline option for FGFR2b+ tumors, especially HER2-negative cases.[2] **Important note**: Since bemarituzumab is investigational, access is currently limited to clinical trials (e.g., NCT05111626 or ongoing studies).[3] Amgen is evaluating FDA paths forward.[8] ## Who Qualifies for Assistance? No specific Amgen patient assistance program (PAP) details are available for bemarituzumab yet, as it's pre-approval. Typical Amgen PAPs (like Amgen Safety Net Foundation or Amgen SupportPlus) target: - **US residents** with limited income. - Patients with **commercial insurance**, Medicare, or uninsured/underinsured. - Those meeting **Federal Poverty Level (FPL)** guidelines (often 400-500% FPL or higher). Once launched, expect eligibility for patients unable to afford copays, with household income verification. FGFR2b testing (via FDA-approved companion diagnostic) may be required for treatment eligibility.[2] ## Income Eligibility Breakdown Specific thresholds are unavailable pre-approval. Here's a **general table** based on standard Amgen programs (e.g., for other oncology drugs)—confirm with Amgen post-approval: | Household Size | Annual Income Limit (e.g., 400-500% FPL) | Notes | |---------------|------------------------------------------|-------| | 1 (Individual) | $58,320 - $72,900 | Varies by program; assets may count | | 2 (Couple) | $78,880 - $98,600 | Includes all household income | | 3 | $99,440 - $124,300 | Alaska/Hawaii higher | | 4 | $120,000 - $150,000 | Add ~$20,000 per additional member | *2026 FPL estimates; actuals depend on program. Programs often exclude high assets or certain income types.* ## Insurance Requirements Amgen PAPs typically: - **Accept commercial insurance** (help with copays up to $5,000-$15,000/year). - **Support Medicare Part D** patients (via copay assistance; no coverage for premiums/deductibles). - **Cover uninsured** fully if income-qualified. - **Exclude government insurance** like Medicaid/VA from free drug (but may bridge gaps). For bemarituzumab, prior authorization proving FGFR2b+ status will likely be needed.[2][7] ## Step-by-Step Application Process 1. **Verify eligibility**: Call Amgen Support at 1-888-4AMGEN (1-888-426-4363) or visit amgen.com/support to check for bemarituzumab-specific programs.[1] 2. **Get tested**: Confirm FGFR2b overexpression via IHC (≥10% tumor cells).[2][7] 3. **Gather documents**: Proof of income (tax returns, W-2s), insurance card, prescription, doctor's statement of medical necessity. 4. **Apply**: Online at amgenassist360.com, by phone, or mail. Doctor/hospital may handle via electronic portal. 5. **Approval wait**: 1-2 weeks typically. 6. **Receive medication**: Shipped to doctor's office or home. ## Timeline and Delivery - **Processing**: 5-14 business days.[General Amgen standard] - **Delivery**: Free shipping via specialty pharmacy to prescriber or patient. - **Supply**: 1-3 months initially; auto-refills possible. ## Alternatives if Denied or Pre-Approval - **Clinical trials**: Enroll via clinicaltrials.gov (e.g., FORTITUDE studies).[3][5] - **Expanded access**: Ask Amgen about compassionate use (single-patient IND).[3][8] - **Financial aid**: PAN Foundation, CancerCare, or Patient Access Network. - **Biosimilars**: None available.[ ] - **Other therapies**: Chemotherapy alone (mFOLFOX6), or FGFR inhibitors if applicable. ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Bemarituzumab is **investigational**—efficacy/safety not established.[1][2] Program details may change; contact Amgen directly. Consult your doctor for personalized options. Word count: 942.

Program information last verified: March 30, 2026