Linvoseltamab
Linvoseltamab (Lynozyfic, Regeneron Ireland Designated Activity Company (DAC)) 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 a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and disease progression on the last therapy; Relapsed and refractory |
Full text of section 4.1 (therapeutic indications)
LYNOZYFIC 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 a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
Label history
1 change to the Lynozyfic label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes