Breyanzi®, lisocabtagene maraleucel, is the newest FDA-approved CD19-directed genetically modified autologous CAR-T cell immunotherapy.

  • It represents a unique product in that it is administered as separate CD8+ and CD4+ CAR+ T cell components at equal target doses, resulting in a consistent administered CD8+ and CD4+ CAR+ T cell dose and low variability in the CD8+/CD4+ ratio.
  • Indicated for the treatment of adult patients with R/R large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma, transformed follicular lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
  • Demonstrated a 73% overall response rate and 54% complete response (CR) rate in the large pivotal TRANSCEND NHL 001 trial.
  • 58% of all patients were alive at 1 year, including 86% of those who achieved a complete response to therapy.
  • Favorable safety profile with only 2% of patients having high-grade (grade 3 or greater) CRS, and 10% of patients having high-grade neurotoxicity.

Mantle Cell Lymphoma

Tecartus® is the first-and-only FDA-approved CD19-directed genetically modified autologous CAR-T cell immunotherapy indicated for the treatment of adult patients with R/R mantle cell lymphoma after first line therapy.

Deep, rapid and durable responses:

  • 87% Overall response rate and 62% complete response (CR) in the ZUMA-2 pivotal trial
  • 1-month median time to response (range: 0.8–3.1 months)
  • The median duration of response was not reached at a median study follow-up of 12.3 months

Indolent Follicular Lymphoma

Yescarta® is the first-and-only FDA-approved CD19-directed genetically modified autologous CAR-T cell immunotherapy indicated for the treatment of adult patients with indolent R/R follicular lymphoma after 2 or more lines of systemic therapy.

Deep, rapid and durable responses:

  • 91% Objective response rate and 60% complete remission rate in the ZUMA -5 pivotal trial.
  • 1-month median time to response
  • 12-month progression-free survival and overall survival rates were 74% and 93%, respectively

Referring patients early can assist in optimal treatment planning due to varying product-manufacturing times that can take between two to four weeks. Please call (404) 255-1930 to initiate a referral or speak to a physician.