Ifinatamab deruxtecan B7-H3 SCLC

Indicated For

extensive-stage small cell lung cancer (ES-SCLC)

About This Medication

# Ifinatamab Deruxtecan Patient Guide: How to Get Ifinatamab Deruxtecan at Low or No Cost **Important Note:** As of March 2026, ifinatamab deruxtecan (I-DXd) is an investigational drug developed by Daiichi Sankyo and Merck. It has received **Breakthrough Therapy Designation** from the FDA for treating extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy, but it is not yet FDA-approved or commercially available.[1][2][7] No dedicated patient assistance program (PAP) exists at this time. This guide explains how to access it through clinical trials, manufacturer support pathways, general assistance options, and what to expect when it launches. Contact Daiichi Sankyo (1-877-437-7763) or Merck (1-800-727-5400) for updates.[2][8] ## About Ifinatamab Deruxtecan (I-DXd) Ifinatamab deruxtecan is a **B7-H3-directed antibody-drug conjugate** designed to target and kill cancer cells in ES-SCLC, a fast-growing lung cancer with limited treatment options after initial chemotherapy.[1][4] In the Phase 2 IDeate-Lung01 trial, it showed a **48.2% objective response rate** in 137 patients previously treated with 1-3 lines of therapy, with median progression-free survival of 4.9 months and overall survival of 10.3 months.[4][7][8] Responses occurred quickly (median 1.4 months), and benefits were seen regardless of prior platinum sensitivity.[4] **Side effects** from trials include potential lung issues, low blood counts, fatigue, and nausea—discuss risks with your doctor. It's under review by regulators, with results presented at the 2025 World Conference on Lung Cancer.[4][7] Since it's investigational, access is primarily via clinical trials.[3] ## Who Qualifies for Assistance? Without an approved PAP, eligibility focuses on **clinical trial enrollment** or future commercial support. Key groups: - Adults with **relapsed/refractory ES-SCLC** after platinum chemotherapy.[1][7] - U.S. residents (trials often prioritize this). - Good performance status (able to perform daily activities), no severe lung compromise or uncontrolled illnesses.[3] When approved, expect PAPs from Daiichi Sankyo or Merck to target **uninsured/underinsured patients** meeting federal poverty level (FPL) guidelines, similar to their other programs (e.g., Merck PAP for free meds).[2][8] Income up to 400-500% FPL is common, but details are unavailable now. ## Income Eligibility Breakdown No specific thresholds announced. Below is a **hypothetical table** based on standard manufacturer PAPs (e.g., Merck, Daiichi Sankyo patterns). Verify with manufacturers post-approval. | Household Size | Annual Income Limit (e.g., 400% FPL) | Annual Income Limit (e.g., 500% FPL) | Notes | |---------------|-------------------------------------|-------------------------------------|-------| | 1 (Individual) | ~$60,000 | ~$75,000 | Adjusts yearly for FPL | | 2 (Couple) | ~$81,000 | ~$101,000 | Includes dependents | | 3 | ~$102,000| ~$127,000 | Alaska/Hawaii higher | | 4 | ~$123,000| ~$153,000 | Excludes certain assets | **FPL Notes:** Programs often cover 400-700% FPL; no assets test usually. Medicare patients may qualify separately.[2] ## Insurance Requirements For trials: Insurance not always required; sponsors cover costs.[3] Post-approval expectations: - **Commercial insurance:** Prior authorization likely; PAP bridges copays. - **Medicare/Medicaid:** Often ineligible for free drug PAPs but copay assistance possible (e.g., Merck Medicare Access Program). - **Uninsured:** Primary target for free supply. Contact manufacturers for **Benefits Investigation** to check coverage.[8] ## Step-by-Step Application Process **Step 1: Confirm Eligibility.** Ask your oncologist if you qualify for trials (clinicaltrials.gov, NCT05280470) or compassionate use.[3] **Step 2: Contact Manufacturers.** Call Daiichi Sankyo Access Services (1-855-468-3732 est.) or Merck Access (1-800-727-5400). Request PAP/enrollment forms.[2][8] **Step 3: Gather Documents.** Typically: Proof of income (tax returns, paystubs), prescription, ID, insurance card.[ ] **Step 4: Submit Application.** Online, mail, or phone. Doctor completes clinical sections. **Step 5: Approval Wait.** 1-4 weeks expected. **Step 6: Receive Medication.** Shipped to doctor/pharmacy. For trials: Doctor submits via sponsor portal.[3] ## Timeline and Delivery - **Trial Screening:** 1-2 weeks.[3] - **PAP Processing:** 5-30 days post-approval. - **Delivery:** Free shipping to prescriber's office; patient picks up. - **Supply Duration:** 1-3 months per approval; reapply for refills. Track status via patient portal or phone. ## Alternatives if Denied or Ineligible - **Clinical Trials:** Search clinicaltrials.gov for I-DXd (e.g., IDeate-Lung01 expansions).[3] - **Expanded Access:** Request from FDA/manufacturers if life-threatening.[1] - **General PAPs:** NeedyMeds.org, RxAssist.org, Partnership for Prescription Assistance. - **Financial Aid:** CancerCare, Patient Access Network (PAN) Foundation for copays. - **Biosimilars/Alternatives:** No biosimilars; options like lurbinectedin (Imdelltra), topotecan, or immunotherapy combos. Discuss with doctor.[4] ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Ifinatamab deruxtecan is **not FDA-approved**; availability limited to trials.[1][7] Eligibility/details change—verify with Daiichi Sankyo, Merck, or healthcare provider. Programs may have restrictions (e.g., no Medicare). Consult professionals for personalized guidance. Word count: ~950.

Program information last verified: March 30, 2026