COFEPRIS CAR-T therapies review: What You Need to Know

Key Takeaways

• First Spanish-speaking authorization: COFEPRIS issued the first import permit for lentiviral vectors in 2023, enabling the Universidad Autónoma de Nuevo León (UANL) to conduct CAR-T research. This made Mexico the first Spanish-speaking country to authorize this therapeutic approach.
• Established products: Globally approved CAR-T therapies include tisagenlecleucel (Kymriah), FDA-approved in August 2017 for B-cell acute lymphoblastic leukemia and large B-cell lymphoma, and axicabtagene ciloleucel (Yescarta), FDA-approved in October 2017 for diffuse large B-cell lymphoma.
• Regulatory framework in development: COFEPRIS established an expert working group on advanced therapies in 2023 to develop standardized criteria for manufacturing quality, clinical evaluation, and safety monitoring of CAR-T therapies in Mexico.
• Active institutional research: UANL's Hospital Universitario Dr. José Eleuterio González received authorization to import lentiviral vectors for CAR-T therapy research, positioning it to become Mexico's first public institution offering this treatment.
• Safety considerations: CAR-T therapies require specialized monitoring for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), managed with tocilizumab and corticosteroids per FDA protocols.

What Are CAR-T Cell Therapies?

CAR-T (Chimeric Antigen Receptor T-cell) therapies represent a class of personalized cell therapies. The treatment involves collecting a patient's T-cells through leukapheresis, genetically modifying them ex vivo to express a receptor targeting CD19 (a surface protein on B-cell cancers), expanding the modified cells in a laboratory, and reinfusing them into the patient.

Once reinfused, the CAR-T cells recognize and bind to CD19-expressing malignant cells, triggering their destruction. This mechanism has demonstrated durable remissions in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL).

Which CAR-T Therapies Has COFEPRIS Authorized?

COFEPRIS has approved commercial CAR-T therapies for aggressive lymphomas in Mexico. The regulatory authorization aligns with globally established products that have undergone extensive clinical evaluation.

Tisagenlecleucel (Kymriah) received FDA approval in August 2017 for two indications: patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse, and adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The FDA approval was based on pivotal trials demonstrating significant response rates in these populations.

Axicabtagene ciloleucel (Yescarta) received FDA approval in October 2017 for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. The FDA expanded this approval in April 2022 to include patients refractory to first-line chemoimmunotherapy or relapsing within 12 months.

What Clinical Research Is Underway in Mexico?

The Universidad Autónoma de Nuevo León (UANL) is conducting pioneering CAR-T research at its Hospital Universitario Dr. José Eleuterio González in Monterrey. In 2023, COFEPRIS granted UANL the first import permit for a lentiviral vector in Mexico, enabling the institution to proceed with clinical research on CAR-T therapy for blood cancer patients.

This authorization allows UANL to become the first public institution in Mexico to implement CAR-T cell therapy. The research focuses on developing local manufacturing capabilities and evaluating safety and efficacy in Mexican patients with CD19-positive malignancies. The initiative represents a significant step toward domestic production of advanced cellular therapies in Latin America.

How Does COFEPRIS Regulate CAR-T Therapies?

In 2023, COFEPRIS established an expert working group dedicated to advanced therapies. This group is developing a comprehensive regulatory framework for CAR-T cell therapies that addresses manufacturing quality standards, clinical efficacy evaluation criteria, safety monitoring requirements, and post-market surveillance protocols.

The framework aims to align with international standards from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) while adapting to Mexico's healthcare infrastructure. Key focus areas include standardized protocols for managing adverse events such as cytokine release syndrome and neurologic toxicities.

What Safety Monitoring Is Required?

CAR-T therapies require specialized safety monitoring due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS occurs when activated CAR-T cells trigger a systemic inflammatory response. ICANS involves neurologic toxicities that can manifest as confusion, aphasia, or seizures.

FDA-approved management protocols include the IL-6 receptor antagonist tocilizumab for CRS and corticosteroids for both CRS and ICANS. Treatment centers must maintain these medications on-site and provide intensive monitoring for at least seven days following CAR-T infusion. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine is required before infusion to enhance CAR-T cell expansion.

What Is the Market Impact in Mexico?

COFEPRIS's authorization of CAR-T therapies addresses an unmet medical need for Mexican patients with relapsed or refractory aggressive lymphomas. Prior to this approval, patients requiring CAR-T therapy faced limited options, including travel to international treatment centers or participation in clinical trials.

The regulatory approval enables commercial distribution and reimbursement pathways outside research protocols. However, CAR-T therapy costs typically exceed USD 300,000 per patient globally, creating challenges for healthcare system integration. Market penetration will depend on pricing negotiations, reimbursement policies, and healthcare provider adoption of specialized administration and monitoring protocols.

Frequently Asked Questions

Primary Sources

1. U.S. Food and Drug Administration. Kymriah (tisagenlecleucel) Approval Information. Accessed 2026.
2. U.S. Food and Drug Administration. Yescarta (axicabtagene ciloleucel) Approval Information. Accessed 2026.
3. Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS). COFEPRIS entrega primer permiso de importación de vector para tratamiento CAR-T. Gobierno de México, 2023.
4. U.S. Food and Drug Administration. Kymriah Prescribing Information. August 2017.
5. U.S. Food and Drug Administration. Yescarta Prescribing Information. October 2017.

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• tisagenlecleucel
• axicabtagene ciloleucel

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