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. 2024 Apr 22;16(8):1599. doi: 10.3390/cancers16081599

Table 2.

Overview of the approved CAR T-cell products with indications.

Trade Name Generic Name Targeted Antigen Costimulatory Domains FDA Approval EMA Approval
KYMRIAH® Tisagen-
lecleucel
CD19 4-1BB
  • -

    Patients ≤ 25 yo with B-cell precursor ALL that is refractory or in second or later relapse.

  • -

    Adult patients with r/r LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified, HGBL, and DLBCL arising from FL. Limitations of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma.

  • -

    Adult patients with r/r FL after two or more lines of systemic therapy [17].

  • -

    Patients ≤ 25 yo with B-cell ALL that is refractory, in relapse post-transplant or in second or later relapse.

  • -

    Adult patients with r/r DLBCL after two or more lines of systemic therapy.

  • -

    Adult patients with r/r FL after two or more lines of systemic therapy [23].

YESCARTA® Axicabtagene
ciloleucel
CD19 CD28
  • -

    Adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

  • -

    Adult patients with r/r LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified, PMBCL, HGBL, and DLBCL arising from FL.

  • -

    Adult patients with r/r FL after two or more lines of systemic therapy [12].

  • -

    Adult patients with DLBCL and HGBL that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

  • -

    Adult patients with r/r DLBCL and PMBCL, after two or more lines of systemic therapy.

  • -

    Adult patients with r/r FL after three or more lines of systemic therapy [18].

TECARTUS® Brexucabtagene
autoleucel
CD19 CD28
  • -

    Adult patients with r/r MCL.

  • -

    Adult patients with r/r B-cell precursor ALL [13].

  • -

    Adult patients with r/r MCL after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

  • -

    Patients ≥ 26 yo with r/r B-cell precursor ALL [19].

ABECMA® Idecabtagene vicleucel BCMA 4-1BB
  • -

    Adult patients with r/r MM after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody [15].

  • -

    Adult patients with r/r MM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression with the last therapy [21].

BREYANZI® Lisocabtagene maraleucel CD19 4-1BB
  • -

    Adult patients with LBCL, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), HGBL, PMBCL, and FL grade 3B, who have the following:

  • -

    A refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy;

  • -

    A refractory disease to first-line chemoimmunotherapy or a relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age;

  • -

    An r/r disease after two or more lines of systemic therapy [16].

  • -

    Adult patients with DLBCL, HGBL, PMBCL, and FL grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

  • -

    Adult patients with r/r DLBCL, PMBCL, and FL grade 3B, after two or more lines of systemic therapy [22].

CARVYKTI® Ciltacabtagene autoleucel BCMA 4-1BB
  • -

    Adult patients with r/r MM after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody [14].

  • -

    Adult patients with r/r MM, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression with the last therapy [20].

Abbreviations: ALL, acute lymphoblastic leukemia; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; HGBL, high-grade B-cell lymphoma; LBCL, large B-cell lymphoma; MCL, mantle cell lymphoma; MM, multiple myeloma; PMBCL, primary mediastinal B-cell lymphoma; r/r, relapsed/refractory. Treatment indications of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are generally comparable but differ in some minor aspects. Therefore, treating physicians have to be aware of the marketing authorization of their specific region (February 2024).