T-cell lymphoma

The EU has approved 6 indications of 4 drugs in T-cell lymphoma. 2 of them need a biomarker result: ALK (1) and CD30 (1).

Site

Line of therapy

Approved indications, T-cell lymphoma
DrugBiomarker requirementRegimenSettingConditions
ALK fusion1
Crizotinib
Xalkori
Monotherapy
2L
Systemic ALCL only; Children and adolescents only; Relapsed or refractory; Age ≥ 1 to < 18 years
CD30-positive1
CD30+
Monotherapy
2L
Cutaneous T-cell lymphoma only; After at least 1 prior systemic therapy
No biomarker required4
None
+ cyclophosphamide, doxorubicin and prednisone
1L
Systemic ALCL only
Bexarotene
Targretin
None
Monotherapy
2L
advanced
Cutaneous T-cell lymphoma only; After at least one systemic treatment; Skin manifestations
None
Monotherapy
2L
Systemic ALCL only; Relapsed or refractory disease
Mogamulizumab
Poteligeo
None
Monotherapy
2L
Cutaneous T-cell lymphoma only; After at least one prior systemic therapy

Biomarkers in T-cell lymphoma

Label wording6

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Mogamulizumab (Poteligeo)
    POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
  2. Crizotinib (Xalkori)
    The treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)
  3. Brentuximab vedotin (Adcetris)
    ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1).
  4. Brentuximab vedotin (Adcetris)
    ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL.
  5. Brentuximab vedotin (Adcetris)
    ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).
  6. Bexarotene (Targretin)
    Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult patients refractory to at least one systemic treatment.