Teclistamab
Teclistamab (Tecvayli) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma2 | |||
None | + daratumumab | 2L | After at least one prior therapy; Relapsed or refractory |
None | Monotherapy | 3L+ | After at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody; disease progression on the last therapy; Relapsed and refractory |
Full text of section 4.1 (therapeutic indications)
TECVAYLI is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Label history
10 changes to the Tecvayli label since 2023, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes