Cell Therapy / Oncology — Hematologic

Yescarta (axicabtagene ciloleucel)

Kite Pharma (Gilead) · CAR-T Cell Therapy — CD19-directed

FDA Approved 2017 IV infusion (autologous, patient-specific product) Specialty Medication
Yescarta axicabtagene ciloleucel CAR-T cell therapy suspension for IV infusion, patient-specific infusion bag, Kite Pharma

What is Yescarta? Yescarta (axicabtagene ciloleucel) is an anti-CD19 CAR-T cell therapy by Kite Pharma (Gilead). It is FDA-approved for relapsed or refractory large B-cell lymphoma and follicular lymphoma after two or more lines of systemic therapy.

About Yescarta

Brand NameYescarta
Generic / INNaxicabtagene ciloleucel
Drug ClassCAR-T Cell Therapy — CD19-directed
ManufacturerKite Pharma (Gilead)
AdministrationIV infusion (autologous, patient-specific product)
FDA Approval2017
📦 Patient-specific autologous product — no standard NDC. Each infusion bag is manufactured for one patient only and is not interchangeable.

FDA-Approved Uses for Yescarta

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • Relapsed or refractory large B-cell lymphoma (LBCL) after 2+ prior systemic therapies (including DLBCL, PMBCL, high-grade B-cell lymphoma, transformed follicular lymphoma)
  • Relapsed or refractory follicular lymphoma (FL) after 2+ prior systemic therapies
  • Relapsed or refractory LBCL — as second-line therapy in patients not intended for hematopoietic stem cell transplant
Biomarker Note: CD19 expression on lymphoma cells is the therapeutic target but not required by the label as a pre-treatment test. Prior therapy requirements (2+ lines for most indications) must be confirmed.

How Does Yescarta Work?

Yescarta consists of the patient's own T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 — a protein expressed on malignant B cells in LBCL and FL. After infusion, CAR-T cells recognize and destroy CD19-positive lymphoma cells.

Dosage & Administration

Single IV infusion of 2 × 10⁶ anti-CD19 CAR-T cells per kg body weight (max 2 × 10⁸ cells). Requires lymphodepleting chemotherapy (fludarabine + cyclophosphamide) 2–7 days before infusion. Must be administered at a REMS-certified facility. Patients monitored for at least 7 days post-infusion.

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

BOXED WARNING: Cytokine release syndrome (CRS) — severe or life-threatening. BOXED WARNING: Neurologic toxicity (ICANS) — severe or life-threatening. Hemophagocytic lymphohistiocytosis. Prolonged cytopenias. Hypogammaglobulinemia. Secondary T-cell malignancies. Available ONLY through the Yescarta REMS Program.

⛔ Serious Warnings & Precautions
  • Cytokine release syndrome (CRS) — boxed warning
  • Neurologic toxicity / ICANS — boxed warning
  • Hemophagocytic lymphohistiocytosis (HLH)
  • Secondary T-cell malignancies
  • Prolonged cytopenias
  • Infections

Common Side Effects

  • CRS (fever, hypotension, hypoxia)
  • Neurologic toxicity
  • Cytopenias
  • Infections
  • Fatigue
  • Hypotension
  • Hypogammaglobulinemia

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Cryopreserved in liquid nitrogen vapor phase (≤ −150°C). Must be stored and thawed per institutional protocol at certified facilities only.

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Yescarta is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Yescarta. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Yescarta

Yescarta (axicabtagene ciloleucel) is a CD19-directed CAR-T cell therapy for relapsed or refractory large B-cell lymphoma and follicular lymphoma. It is a one-time infusion made from the patient's own T cells.

Yescarta targets CD19 on B-cell lymphomas, while Abecma targets BCMA on multiple myeloma cells. Both are autologous CAR-T therapies, but they treat different cancers and are not interchangeable.

CRS is a systemic inflammatory reaction that can occur within days of CAR-T infusion, ranging from mild fever to severe multi-organ dysfunction. All patients must remain near the certified treatment center for monitoring for at least 7 days after Yescarta infusion.

Only at healthcare facilities certified through the Yescarta REMS Program, with 24/7 access to tocilizumab and ICU-level care.

Yescarta is covered by commercial insurance and Medicare for eligible patients with extensive prior authorization documentation. Patient support programs are available. BiologicHealthPlus assists with access coordination and benefits verification.

Related Medications

Kymriah (tisagenlecleucel)  ·  Breyanzi (lisocabtagene maraleucel)  ·  Carvykti (ciltacabtagene)  ·  Abecma

Related Conditions

Diffuse large B-cell lymphoma (DLBCL)  ·  Follicular lymphoma  ·  Large B-cell lymphoma  ·  Relapsed/refractory lymphoma

Comparisons

Abecma

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.