{
  "abstract": "Following administration of chimeric antigen receptor (CAR) T-cell therapy, extensive long-term follow-up (LTFU) requirements and complex data collection processes have posed significant challenges for patients and providers. To reassess whether a 15-year LTFU period remains scientifically justified, we convened a multistakeholder working group that included representatives from patient advocacy groups, academia, industry, and government. This analysis incorporates newly aggregated primary data on composite percentages of adverse events (AEs) reported by year for five Food and Drug Administration-approved CAR T-cell therapies. Combined with previously published research, the findings indicate that AEs are infrequently reported after 3 years post-infusion, and secondary T-cell malignancy—the AE of primary concern based on the mechanism of action of CAR T-cell therapy—has predominantly been reported within the first 2 years. Based on current cumulative safety data, a 5-year follow-up period may be scientifically sufficient in both clinical trial and commercial settings. Additionally, we propose a streamlined process that leverages technological advancements to automate the transfer of focused safety data from electronic health records into a third-party database. To facilitate implementation, we recommend feasibility testing of this updated data collection approach using an established platform. We also outline regulatory policy considerations to most effectively enable adoption of these recommendations.",
  "authors": [
    {
      "affiliations": [
        "Catalyst Healthcare Consulting Inc, McLean, Virginia, USA"
      ],
      "name": "Betsy Foss-Campbell"
    },
    {
      "affiliations": [
        "Catalyst Healthcare Consulting Inc, McLean, Virginia, USA"
      ],
      "name": "Nancy Myers"
    },
    {
      "affiliations": [
        "Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"
      ],
      "name": "Rakesh Awasthi"
    },
    {
      "affiliations": [
        "J&J, New Brunswick, New Jersey, USA"
      ],
      "name": "Dylan Bechtle"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, New Jersey, USA"
      ],
      "name": "Mariette Boerstoel Streefland"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, New Jersey, USA"
      ],
      "name": "Wendy Corbett"
    },
    {
      "affiliations": [
        "Artiva Biotherapeutics Inc, San Diego, California, USA"
      ],
      "name": "Benjamin Dewees"
    },
    {
      "affiliations": [
        "Emily Whitehead Foundation, Philipsburg, Pennsylvania, USA"
      ],
      "name": "George Eastwood"
    },
    {
      "affiliations": [
        "University of Pennsylvania, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Julie Jadlowsky"
    },
    {
      "affiliations": [
        "Kite Pharma Inc, Santa Monica, California, USA"
      ],
      "name": "Lisa Joy Martin"
    },
    {
      "affiliations": [
        "A2 Biotherapeutics Inc, Agoura Hills, California, USA"
      ],
      "name": "Wendy Langeberg"
    },
    {
      "affiliations": [
        "J&J, New Brunswick, New Jersey, USA"
      ],
      "name": "Erin Lee"
    },
    {
      "affiliations": [
        "University of Pennsylvania, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Amy Marshall"
    },
    {
      "affiliations": [
        "Blood Cancer United, Rye Brook, New York, USA"
      ],
      "name": "Gwen Nichols"
    },
    {
      "affiliations": [
        "Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"
      ],
      "name": "Jamie Shapiro"
    },
    {
      "affiliations": [
        "Kite Pharma Inc, Santa Monica, California, USA"
      ],
      "name": "Lana Shiu"
    },
    {
      "affiliations": [
        "Friends of Cancer Research, Washington, District of Columbia, USA"
      ],
      "name": "Mark Stewart"
    },
    {
      "affiliations": [
        "National Institutes of Health, Bethesda, Maryland, USA"
      ],
      "name": "Nicholas P Tschernia"
    },
    {
      "affiliations": [
        "Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"
      ],
      "name": "Jennifer Willert"
    },
    {
      "affiliations": [
        "Kite Pharma Inc, Santa Monica, California, USA"
      ],
      "name": "Hairong Xu"
    },
    {
      "affiliations": [
        "University of Pennsylvania, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Carl H June"
    }
  ],
  "title": "Data-informed optimization of CAR T-cell therapy long-term follow-up",
  "uid": "6eebd2cb-63ef-5bcc-a750-50a8531e0b84"
}