|
SMC2943
|
08/06/2026
|
tafasitamab (Minjuvi)
|
Non submission
|
Tafasitamab is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
|
|
|
SMC2914
|
09/03/2026
|
isatuximab (Sarclisa®)
|
Non submission
|
In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
|
|
|
SMC2804
|
10/11/2025
|
isatuximab (Sarclisa)
|
Full
|
In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
|
|
|
SMC2747
|
13/10/2025
|
belantamab mafodotin (Blenrep)
|
Full
|
In combination with pomalidomide and dexamethasone (BPd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy including lenalidomide.
|
|
|
SMC2727
|
13/10/2025
|
belantamab mafodotin (Blenrep)
|
Full
|
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
|
|
|
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.
|
|
|
SMC2674
|
07/10/2024
|
selinexor (Nexpovio)
|
Full
|
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior 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).
|
|
|
SMC2522
|
09/05/2023
|
tafasitamab (Minjuvi)
|
Full
|
In combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
|
|
|
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.
|
|
|
SMC2407
|
09/08/2021
|
elotuzumab (Empliciti)
|
Non submission
|
In combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
|
|
|
SMC2303
|
12/04/2021
|
isatuximab (Sarclisa)
|
Full
|
In combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.
|
|
|
SMC2290
|
12/10/2020
|
carfilzomib (Kyprolis)
|
Resubmission
|
In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
|
|
|
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.
|
|
|
SMC2289
|
12/10/2020
|
lenalidomide (Revlimid)
|
Full
|
As monotherapy is indicated in multiple myeloma (MM) for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation (ASCT).
|
|
|
SMC2281
|
12/10/2020
|
lenalidomide (Revlimid)
|
Full
|
In combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated Follicular Lymphoma (Grade 1 - 3a).
|
|
|
SMC2217
|
12/08/2019
|
lenalidomide (Revlimid)
|
Non submission
|
As combination therapy with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
|
|
|
SMC2219
|
12/08/2019
|
pomalidomide (Imnovid)
|
Non submission
|
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
|
|
|
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.
|
|
|
SMC2099
|
09/07/2018
|
ixazomib (Ninlaro)
|
Non submission
|
in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
|
|