CAR T-Cell FDA Investigation: Addressing Concerns & Managing CAR T-Cell Referrals for Community Oncologists

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Chimeric antigen receptor (CAR) T-cell therapies have transformed patient outcomes and treatment approaches for patients with difficult-to-treat hematologic malignancies, leading to improved overall survival compared to traditional salvage treatment options. However, recent reports of rare secondary T-cell malignancies, which led to an FDA investigation and subsequent black box warning for all CAR T-cell therapies, caused confusion among patients and clinicians related to the safety and role of CAR T-cell therapy. Gilles Salles, MD, PhD, provides his insights to address this confusion by clarifying the benefits vs risks of CAR T-cell therapies, with recommendations for patient education, referrals, and treatment integration and individualization.

Course Credit:

0.50 AMA PRA Category 1 CreditsTM

Dates:

Opens: 2025-02-27
Closes: 2026-02-27

Target Audience:

This activity is intended for medical hematologists/oncologists, pharmacists, nurse practitioners, physician associates, nurses, and other team members such as hospitalists and emergency medicine clinicians, and staff who manage patients with serious CAR T adverse events of novel therapies (including rare secondary malignancies).

This activity is supported by an independent educational grant from Novartis Pharmaceuticals Corporation.

Accreditation Information

Accreditation

In support of improving patient care, Annenberg Center for Health Sciences at Eisenhower (Annenberg Center) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

The Annenberg Center for Health Sciences at Eisenhower designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Additional Content Planners

Chris Elder, PharmD, BCOP (Medical Writer)

Advisory Board: Boehringer Ingelheim, Eisai, Janssen, Mirati, Novartis, Pharmacosmos, Pfizer, Sanofi


Annenberg Center for Health Sciences

Staff at the Annenberg Center for Health Sciences at Eisenhower have no relevant financial relationships to disclose.

All of the financial relationships listed for these individuals have been mitigated.

    Presenting Faculty

  • Gilles Salles, MD, PhD

    Service Chief, Lymphoma Service
    Steven Greenberg Chair
    Memorial Sloan Kettering Cancer Center
    Weill Cornell Medical College
    New York, New York

Learning Objectives

  • Review CAR T clinical evidence, risk vs. benefit profile, and current place in oncology care.
  • Discuss FDA announcement on CAR T therapies, the intent and purpose of the investigation, and the FDA process moving forward.
  • Develop best practice recommendations for CAR T therapy referrals and treatment in hematologic malignancies.
  • Integrate strategies to enhance patient education and shared decision-making surrounding CAR T therapies.

Faculty Disclosures

Gilles Salles, MD, PhD

Advisory Board: AbbVie, BMS, Genentech, Genmab, Kite Gilead, Novartis, Pfizer

Data Monitoring Safety Board: BeiGene