Large B-cell lymphoma

The EU has approved 15 indications of 10 drugs in large B-cell lymphoma. 2 of them need a biomarker result: CD20 (2).

Approved indications, Large B-cell lymphoma
Drug	Biomarker requirement	Regimen	Setting	Conditions

CD20-positive2
Rituximab MabThera		+ chemotherapy	1L advanced	DLBCL only; Children and adolescents only; Aged 6 months to less than 18 years old
Rituximab MabThera		+ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone)	Any line	DLBCL only

No biomarker required13
Polatuzumab vedotin Polivy	None	+ rituximab, cyclophosphamide, doxorubicin, and prednisone	1L	DLBCL only
Axicabtagene ciloleucel Yescarta	None	Monotherapy	2L	DLBCL or HGBL only; First-line chemoimmunotherapy (relapsed within 12 months from completion or refractory)
Glofitamab Columvi	None	+ gemcitabine and oxaliplatin	2L	DLBCL NOS only; Ineligible for autologous stem cell transplant (ASCT)
Lisocabtagene maraleucel Breyanzi	None	Monotherapy	2L	DLBCL, HGBL or PMBCL only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy
Polatuzumab vedotin Polivy	None	+ bendamustine and rituximab	2L	DLBCL only; Not candidates for haematopoietic stem cell transplant
Tafasitamab Minjuviconditional	None	+ lenalidomide followed by monotherapy	2L	DLBCL only; Not eligible for autologous stem cell transplant (ASCT)
Axicabtagene ciloleucel Yescarta	None	Monotherapy	3L+	DLBCL or PMBCL only; After two or more lines of systemic therapy
Epcoritamab Tepkinlyconditional	None	Monotherapy	3L+	DLBCL only; After two or more lines of systemic therapy
Glofitamab Columvi	None	Monotherapy	3L+	DLBCL only; After two or more lines of systemic therapy
Lisocabtagene maraleucel Breyanzi	None	Monotherapy	3L+	DLBCL or PMBCL only; After two or more lines of systemic therapy
Loncastuximab tesirine Zynlontaconditional	None	Monotherapy	3L+	DLBCL or HGBL only; After two or more lines of systemic therapy; Relapsed or refractory
Odronextamab Ordsponoconditional	None	Monotherapy	3L+	DLBCL only; After two or more lines of systemic therapy
Tisagenlecleucel Kymriah	None	Monotherapy	3L+	DLBCL only; After two or more lines of systemic therapy

Biomarkers in large B-cell lymphoma

CD202

Label wording15

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

Polatuzumab vedotin (Polivy)
Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Polatuzumab vedotin (Polivy)
Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
Glofitamab (Columvi)
Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
Glofitamab (Columvi)
Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Rituximab (MabThera)
MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Rituximab (MabThera)
MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged 6 months to less than 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).
Odronextamab (Ordspono)
Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.
Loncastuximab tesirine (Zynlonta)
Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
Tisagenlecleucel (Kymriah)
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
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.
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.
Epcoritamab (Tepkinly)
Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Axicabtagene ciloleucel (Yescarta)
Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.
Axicabtagene ciloleucel (Yescarta)
Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Tafasitamab (Minjuvi)
MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).