TEPKINLY (epcoritamab) - Diffuse large B-cell lymphoma (DLBCL)
Reason for request
Key points
Favourable opinion for reimbursement as monotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy only in adult patients who have failed or are ineligible for CAR-T cell-based medicinal products.
Unfavourable opinion for reimbursement in the other clinical situations of the MA.
Clinical Benefit
Substantial |
The Committee deems that the clinical benefit of TEPKINLY (epcoritamab) 4 mg/0.8 mL concentrate for solution for injection and 48 mg solution for injection is substantial as monotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy only in adult patients who have failed or are ineligible for CAR-T cell-based medicinal products. |
Insufficient |
The Committee deems that the clinical benefit of TEPKINLY (epcoritamab) 4 mg/0.8 mL concentrate for solution for injection and 48 mg solution for injection is insufficient to justify public funding in the other clinical situations of the MA. |
Clinical Added Value
no clinical added value |
Considering:
the Committee deems that, based on the current data, and pending the results of the phase 3 EPCORE DLBCL-1 trial, TEPKINLY (epcoritamab) as monotherapy provides no clinical added value (CAV V) in the care pathway for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy and who have failed or are ineligible for CAR-T cell-based medicinal products.
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Not applicable |