Follicular lymphoma

The EU has approved 19 indications of 12 drugs in follicular lymphoma. None of them needs a biomarker result.

Grade

Line of therapy

Approved indications, Follicular lymphoma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required19
Obinutuzumab
Gazyvaro
None
+ chemotherapy
1L
advanced
Then maintenance monotherapy
Rituximab
MabThera
None
+ chemotherapy
1L
advanced
None
Obinutuzumab
Gazyvaro
None
Monotherapy
Maint.
advanced
After Gazyvaro in combination with chemotherapy achieving a response
Obinutuzumab
Gazyvaro
None
Monotherapy
Maint.
After Gazyvaro in combination with bendamustine without progression; did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Rituximab
MabThera
None
Monotherapy
Maint.
Responding to induction therapy
Epcoritamab
Tepkinlyconditional
None
+ lenalidomide and rituximab
2L
None
Lenalidomide
Revlimid
None
+ rituximab
2L
Grade 1–3A only; Previously treated
None
Monotherapy
2L
Grade 3B only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy
Obinutuzumab
Gazyvaro
None
+ bendamustine
2L
Then maintenance monotherapy; Did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Rituximab
MabThera
None
Monotherapy
2L
advanced
Chemoresistant or in second or subsequent relapse after chemotherapy
Tafasitamab
Minjuviconditional
None
+ lenalidomide and rituximab
2L
After at least one line of systemic therapy; Grade 1-3a
None
Monotherapy
3L+
After three or more lines of systemic therapy
Epcoritamab
Tepkinlyconditional
None
Monotherapy
3L+
After two or more lines of systemic therapy
Idelalisib
Zydelig
None
Monotherapy
3L+
Refractory to two prior lines of treatment
None
Monotherapy
3L+
After two or more lines of systemic therapy
Mosunetuzumab
Lunsumioconditional
None
Monotherapy
3L+
After at least two prior systemic therapies
Odronextamab
Ordsponoconditional
None
Monotherapy
3L+
After two or more lines of systemic therapy
None
Monotherapy
3L+
After two or more lines of systemic therapy
Zanubrutinib
Brukinsa
None
+ obinutuzumab
3L+
After at least two prior systemic therapies; Relapsed or refractory
Label wording19

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

  1. Zanubrutinib (Brukinsa)
    BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
  2. Mosunetuzumab (Lunsumio)
    Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
  3. Rituximab (MabThera)
    MabThera is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.
  4. Rituximab (MabThera)
    MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.
  5. Rituximab (MabThera)
    MabThera monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
  6. Odronextamab (Ordspono)
    Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.
  7. Tisagenlecleucel (Kymriah)
    Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  8. Lisocabtagene maraleucel (Breyanzi)
    Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
  9. Lisocabtagene maraleucel (Breyanzi)
    Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.
  10. Epcoritamab (Tepkinly)
    Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
  11. Epcoritamab (Tepkinly)
    Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  12. Lenalidomide (Revlimid)
    Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
  13. Axicabtagene ciloleucel (Yescarta)
    Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.
  14. Obinutuzumab (Gazyvaro)
    Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)
  15. Obinutuzumab (Gazyvaro)
    Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)
  16. Obinutuzumab (Gazyvaro)
    Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
  17. Obinutuzumab (Gazyvaro)
    Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
  18. Tafasitamab (Minjuvi)
    MINJUVI is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
  19. Idelalisib (Zydelig)
    Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).