Hodgkin lymphoma

The EU has approved 8 indications of 3 drugs in hodgkin lymphoma. 4 of them need a biomarker result: CD30 (4).

Type

Line of therapy

Approved indications, Hodgkin lymphoma
DrugBiomarker requirementRegimenSettingConditions
CD30-positive4
CD30+
+ doxorubicin, vinblastine and dacarbazine
1L
advanced
None
CD30+
+ etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone
1L
advanced
Stage IIB with risk factors, Stage III or Stage IV
CD30+
Monotherapy
Consol.
Following autologous stem cell transplant (ASCT); At increased risk of relapse or progression
CD30+
Monotherapy
3L+
Following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option
No biomarker required4
Opdivo
None
+ doxorubicin, vinblastine and dacarbazine (AVD)
1L
advanced
Classical Hodgkin lymphoma only; Stage III or IV
Opdivo
None
+ brentuximab vedotin
2L
Classical Hodgkin lymphoma only; After one prior line of therapy; Aged 5 up to 30 years
Opdivo
None
Monotherapy
3L+
Classical Hodgkin lymphoma only; After autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin
None
Monotherapy
3L+
Classical Hodgkin lymphoma only; Failed autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT is not a treatment option; Aged 3 years and older

Biomarkers in hodgkin lymphoma

Label wording8

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

  1. Pembrolizumab (Keytruda)
    KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
  2. Nivolumab (Opdivo)
    OPDIVO in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma.
  3. Nivolumab (Opdivo)
    OPDIVO in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1).
  4. Nivolumab (Opdivo)
    OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
  5. Brentuximab vedotin (Adcetris)
    ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1).
  6. Brentuximab vedotin (Adcetris)
    ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1).
  7. Brentuximab vedotin (Adcetris)
    ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).
  8. Brentuximab vedotin (Adcetris)
    ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.