Glofitamab (2) – Columvi®

Diffuse large B-cell lymphoma, relapsed or refractory, in combination with gemcitabine and oxaliplatin; autologous stem cell transplantation is not suitable

Characteristics

Start date 15.05.2025 – Marketing authorisation: 10.04.2025
Resolution 06.11.2025
INN Glofitamab
Brand name Columvi®
Pharm. company Roche Pharma AG
G-BA Procedure ID D-1206
ATC code L01FX28 Other monoclonal antibodies and antibody drug conjugates (L01FX)
ICD-10 codes (AIS) C83.3Diffuse large B-cell lymphoma
Alpha-ID codes (AIS) I114432Diffuse large B-cell lymphoma
Therapeutic area Oncological diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

COLUMVI, in combination with gemcitabine and oxaliplatin, is used to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS, not otherwise specified), who are not eligible for autologous stem cell transplantation (ASCT).
Subpopulation Indication Comparator
a) Erwachsene mit rezidiviertem oder refraktärem diffusem großzelligem B Zell Lymphom, das nicht anderweitig spezifiziert ist (DLBCL NOS, not otherwise specified), die nicht für eine autologe Stammzelltransplantation (ASCT) geeignet sind, nach Versagen einer Linie systemischer Therapie
b1) Erwachsene mit rezidiviertem oder refraktärem diffusem großzelligem B Zell Lymphom, das nicht anderweitig spezifiziert ist (DLBCL NOS, not otherwise specified), die nicht für eine autologe Stammzelltransplantation (ASCT) geeignet sind und die für eine CAR-T-Zelltherapie oder eine allogene hämatopoetische Stammzelltransplantation infrage kommen, nach Versagen von zwei oder mehr Linien systemischer Therapie
b2) Erwachsene mit rezidiviertem oder refraktärem diffusem großzelligem B Zell Lymphom, das nicht anderweitig spezifiziert ist (DLBCL NOS, not otherwise specified), die nicht für eine CAR-T-Zelltherapie und eine hämatopoetische Stammzelltransplantation geeignet sind, nach Versagen von zwei oder mehr Linien systemischer Therapie

Studies and Results

  • Clinical trials
    • The STARGLO trial is an ongoing, multicentre, open-label, randomised controlled Phase III trial comparing glofitamab in combination with gemcitabine and oxaliplatin with rituximab in combination with gemcitabine and oxaliplatin.

a) Adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), who are not suitable for autologous stem cell transplantation (ASCT), following failure of one line of systemic therapy

  • The additional benefit is not proven.
  • Overall, there are therefore no suitable data available to assess the additional benefit of glofitamab in combination with gemcitabine and oxaliplatin.

b1) Adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not suitable for autologous stem cell transplantation (ASCT) and who are eligible for CAR-T cell therapy or allogeneic haematopoietic stem cell transplantation, following failure of two or more lines of systemic therapy

  • The additional benefit is not proven.
  • Overall, there are therefore no suitable data available to assess the additional benefit of glofitamab in combination with gemcitabine and oxaliplatin.

b2) Adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS, not otherwise specified), who are not suitable for CAR-T-cell therapy and haematopoietic stem cell transplantation, following failure of two or more lines of systemic therapy

  • An additional benefit is not proven.
  • Overall, there are therefore no suitable data available to assess the additional benefit of glofitamab in combination with gemcitabine and oxaliplatin.

Courtesy translation only, please refer to the German original.

Associated procedures



<< List of all resolutions