Talquetamab
Talquetamab (Talvey, Janssen-Cilag International N.V.) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma1 | |||
None | Monotherapy | 3L+ | After at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and demonstrated disease progression on the last therapy |
Full text of section 4.1 (therapeutic indications)
TALVEY is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 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 Talvey label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes