Glofitamab (3) – Columvi®

Diffuse large B-cell lymphoma (DLBCL), following ≥ 2 prior treatments

Characteristics

Start date 15.05.2025 – Marketing authorisation: 07.07.2023
Resolution 06.11.2025
INN Glofitamab
Brand name Columvi®
Pharm. company Roche Pharma AG
G-BA Procedure ID D-1207
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 Reassessment: Loss of orphan status

Therapeutic indication of the resolution

Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following two or more lines of systemic therapy.
Subpopulation Indication Comparator
b) Erwachsene mit rezidiviertem oder refraktärem diffus großzelligem B-Zell-Lymphom (DLBCL) nach mindestens zwei vorherigen systemischen Therapien, die für eine CAR-T-Zelltherapie und Stammzelltransplantation nicht infrage kommen
a) Erwachsene mit rezidiviertem oder refraktärem diffus großzelligem B-Zell-Lymphom (DLBCL) nach mindestens zwei vorherigen systemischen Therapien, die für eine CAR-T-Zelltherapie oder Stammzelltransplantation infrage kommen

Studies and Results

  • Clinical trials
    • The NP30179 trial is a single-arm, ongoing Phase I/II dose-escalation and dose-expansion trial in people with relapsed or refractory (r/r) B-cell non-Hodgkin’s lymphoma.

a) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least two previous systemic therapies, who are eligible for CAR-T cell therapy or stem cell transplantation

  • An additional benefit is not proven.
  • mortality
    • Due to its single-arm study design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of the endpoints and is therefore not suitable for assessing the additional benefit of glofitamab as monotherapy.
  • morbidity
    • Due to its single-arm design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of the research questions and is therefore not suitable for assessing the additional benefit of glofitamab as monotherapy.
  • Health-related quality of life
    • Due to its single-arm design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of these research questions and is therefore not suitable for assessing the additional benefit of Glofitamab as monotherapy.
  • Side effects
    • Due to its single-arm design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of these research questions and is therefore not suitable for assessing the additional benefit of Glofitamab as monotherapy.

b) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least two previous systemic therapies, who are not eligible for CAR-T cell therapy or stem cell transplantation

  • An additional benefit is not proven.
  • mortality
    • Due to its single-arm study design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of the research questions and is therefore not suitable for assessing the additional benefit of glofitamab as monotherapy.
  • morbidity
    • Due to its single-arm design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of the research questions and is therefore not suitable for assessing the additional benefit of glofitamab as monotherapy.
  • Health-related quality of life
    • Due to its single-arm design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of these research questions and is therefore not suitable for assessing the additional benefit of Glofitamab as monotherapy.
  • Side effects
    • Due to its single-arm design, the NP30179 study does not allow for a comparison with the appropriate comparator therapy for either of the research questions and is therefore not suitable for assessing the additional benefit of Glofitamab as monotherapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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