FDA Black Box Warning for CAR-T cell therapies highlights the necessity for long-term monitoring

FDA Black Box Warning for CAR-T therapies: Don’t Panic, but Do Long-Term Monitoring.

Since November 2023, the FDA has been closely monitoring postmarketing adverse event and clinical trial reports describing the occurrence of mature T cell malignancies, including CAR-positive tumors, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. The findings from this have recently resulted in a class wide black box warning requirement for six commercial CAR-T therapies (A black box warning is the most serious safety alert on a medication’s label).

Second primary malignancies (SPMs) were reported in 536 out of 12,394 (4.3%) adverse event reports following CAR T cell therapies in the FDA Adverse Event Reporting System (FAERS) with T-cell malignancies representing only 0.1% of the reports. (Citation “Second Primary Malignancies After Commercial CAR T Cell Therapy: Analysis of FDA Adverse Events Reporting System (FAERS) Magdi Elsallab, et.al 14-Mar-2024 – ASH Publications & Incidence of Secondary T-Cell Malignancies Following CAR T-Cell Therapy – ASCO Post/Publications)

Exemplary image for Pharmacovigilance and Long-term Follow-up

CRO Expertise Crucial for Long-Term CAR-T Cell Monitoring

As this is notably lower than that reported for more conventional alternative treatments and it is generally agreed that the benefits far outweigh the risks by both the FDA and industry professionals, there isn’t a strong consensus to change the trajectory in CAR-T cell immunotherapy treatments and clinical trials. However, there should be long term/life-long monitoring for new malignancies to ensure understanding of the risk factors involved.

Based on FDA guidance in monitoring the persistence of CAR-T cells during the clinical trial and for long-term follow-up for a minimum of 15 years, including funding, in the event the sponsor ceases to operate or decides to inactivate, transfer, or withdraw the IND before completion of the long term follow up, partnering with an experienced CRO provides the expertise and support through the full development lifecycle.

At Oncobay (soon to be Kapadi), safety is our watchword. We understand the critical importance of long-term follow-up studies in CAR-T cell therapies, as highlighted by the recent FDA Black Box Warning. With our extensive expertise in safety monitoring and long-term follow-up, we are the ideal partner for sponsors seeking to ensure the safety of their patients and the integrity of their clinical trials. Our unwavering commitment to safety, combined with our proven track record of supporting long-term follow-up studies for over a decade, makes us the trusted choice for sponsors who prioritize patient well-being and regulatory compliance.

Take Advantage of OncoBay’s Innovative Approach


Submit a Request for Proposal

Submit Proposal

OncoBay is now Kapadi


Once three entities – OncoBay Clinical, Clinscience, and Exom Group s.r.l – now we stand as one, bringing forth a symphony of expertise and seamless operations. To celebrate our unity, we re-brand under the banner of Kapadi, and embark on a new chapter of exceptional service in oncology clinical research.

Kapadi is not just a name; it's a testament to our fusion. It signifies the our standing as a global CRO powerhouse committed to accelerating groundbreaking cancer therapies that uplift patients worldwide. From conceptualizing studies, navigating regulations, and analyzing data, we provide a comprehensive array of services designed to empower your oncology clinical trials.


Visit Kapadi.com


This pop-up will auto-close in 10 seconds.

This will close in 5 seconds