Epcoritamab (2) – Tepkinly®

Follicular lymphoma, after ≥ 2 prior therapies

Characteristics

Start date 15.09.2024 – Marketing authorisation: 16.08.2024
Resolution 06.03.2025
INN Epcoritamab
Brand name Tepkinly®
Pharm. company AbbVie Deutschland GmbH & Co. KG
G-BA Procedure ID D-1106
ATC code n.d.
ICD-10 codes (AIS) C82.0Follicular lymphoma grade I, C82.1Follicular lymphoma grade II, C82.2Follicular lymphoma grade III, unspecified, C82.3Follicular lymphoma grade IIIa, C82.4Follicular lymphoma grade IIIb, C82.7, C82.9Follicular lymphoma, unspecified
Alpha-ID codes (AIS) I116042Follicular lymphoma grade 1, I116043Follicular lymphoma grade 2, I116044Follicular lymphoma grade 3, I116045Follicular lymphoma grade 3a, I116046Follicular lymphoma grade 3b, I116049Other types of follicular lymphoma, I17968Follicular lymphoma
Therapeutic area Oncological diseases Follicular lymphoma (FL)
Reason for procedure New therapeutic indication
Regulatory status Conditional Approval

Therapeutic indication of the resolution

Tepkinly is used as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 lines of systemic therapy
Subpopulation Indication Comparator
Adults with relapsed or refractory follicular lymphoma (FL) after at least 2 lines of systemic therapy Individualised therapy under selection of – Bendamustine + obinutuzumab followed by obinutuzumab maintenance therapy according to the marketing authorisation, – Lenalidomide + rituximab, – Rituximab monotherapy, – mosunetuzumab and – tisagenlecleucel

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)

Adults with relapsed or refractory follicular lymphoma (FL) following at least two lines of systemic therapy

  • Additional benefit is not proven for epcoritamab as monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma (FL) following at least two lines of systemic therapy.
  • The results of the single-arm study do not allow for a comparison with the appropriate comparator therapy and are not suitable for assessing additional benefit.
  • Consequently, additional benefit from epcoritamab as monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma (FL) is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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