|
SMC2895
|
19/01/2026
|
daratumumab (Darzalex)
|
Non submission
|
As monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma
|
|
|
SMC2673
|
07/10/2024
|
selinexor (Nexpovio)
|
Full
|
In combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
|
|
|
SMC2536
|
11/09/2023
|
daratumumab (Darzalex)
|
Full
|
Daratumumab in combination with lenalidomide and dexamethasone (DLd) is licensed for use for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).
|
|
|
SMC2447
|
08/08/2022
|
daratumumab (Darzalex)
|
Full
|
In combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
|
|
|
SMC2416
|
09/05/2022
|
daratumumab IV and SC (Darzalex)
|
Full
|
In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
|
|
|
SMC2484
|
11/04/2022
|
carfilzomib (Kyprolis)
|
Non submission
|
In combination with daratumumab and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
|
|
|
SMC2469
|
07/03/2022
|
daratumumab (Darzalex®)
|
Non submission
|
In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.
|
|
|
SMC2302
|
18/01/2021
|
daratumumab (Darzalex)
|
Full
|
In combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
|
|
|
SMC2326
|
18/01/2021
|
daratumumab (Darzalex)
|
Abbreviated
|
In combination with bortezomib, thalidomide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
|
|
|
SMC2301
|
12/10/2020
|
daratumumab (Darzalex)
|
Abbreviated
|
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
|
|
|
SMC2304
|
12/10/2020
|
daratumumab (Darzalex)
|
Abbreviated
|
As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
|
|
|
SMC2180
|
08/07/2019
|
daratumumab (Darzalex)
|
Full
|
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
|
|
|
1205/17
|
09/10/2017
|
daratumumab (Darzalex)
|
Resubmission
|
As monotherapy, for the treatment of adult patients with relapsed and refectory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and have demonstrated disease progression on the last therapy.
|
|
