Epcoritamab (3) – Tepkinly®

Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies

Characteristics

Start date 01.11.2024 – Marketing authorisation: 22.09.2023
Resolution 17.04.2025
INN Epcoritamab
Brand name Tepkinly®
Pharm. company AbbVie Deutschland GmbH & Co. KG
G-BA Procedure ID D-1133
ATC code n.d.
ICD-10 codes (AIS) C83.3Diffuse large B-cell lymphoma
Alpha-ID codes (AIS) I114432Diffuse large B-cell lymphoma
Therapeutic area Oncological diseases B-cell lymphoma (DLBCL / PMBCL)
Reason for procedure Reassessment: Loss of orphan status
Original resolution: Epcoritamab (1) (04.04.2024)
Regulatory status Conditional Approval
Specialty ACT change

Therapeutic indication of the resolution

Tepkinly is used as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least 2 lines of systemic therapy.
Subpopulation Indication Comparator
a) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior systemic therapies who are eligible for CAR-T cell therapy or stem cell transplantation Individualised therapy under selection of – Tisagenlecleucel, – axicabtagene ciloleucel, – Lisocabtagen maraleucel, – induction therapy with – R-GDP (rituximab, gemcitabine, dexamethasone, cisplatin or carboplatin) or – R-DHAP (rituximab, dexamethasone, cisplatin, cytarabine) or – R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by high-dose therapy with autologous stem cell transplantation if there is a response to induction therapy and – induction therapy with – R-GDP (rituximab, gemcitabine, dexamethasone, cisplatin or carboplatin) or – R-DHAP (rituximab, dexamethasone, cisplatin, cytarabine) or – R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by high-dose therapy with allogeneic stem cell transplantation if there is a response to induction therapy
b) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior systemic therapies who are not eligible for CAR-T cell therapy and stem cell transplantation Individualised therapy under selection of – Polatuzumab vedotin + bendamustine + rituximab, – tafasitamab + lenalidomide and – radiotherapy

Studies and Results

No. of studies
(best subpopulation) 		1 (GCT3013-01) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Single-arm + no comparison)
Reason for dividing into subpopulations (G-BA) Patient eligibility
ACT change 29.10.2024 – Stellungnahme der Fachgesellschaften

  • Clinical trials
    • The GCT3013-01 trial is a single-arm, ongoing Phase I/II trial in adults with various forms of relapsed/refractory (r/r) B-cell 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

  • For patient group a), the additional benefit is not proven.
  • Due to its single-arm design, the study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy.
  • Overall, the data submitted are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of epcoritamab as monotherapy for the treatment of adults with r/r DLBCL following at least two lines of systemic therapy is not proven.

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 and stem cell transplantation

  • For patient group b), the additional benefit is not proven.
  • Due to its single-arm design, the study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy.
  • Overall, the data submitted are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of epcoritamab as monotherapy for the treatment of adults with r/r DLBCL following at least two lines of systemic therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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