|
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).
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
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).
|
|
|
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.
|
|
|
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.
|
|
|
1122/16
|
07/02/2016
|
panobinostat (Farydak)
|
Full
|
in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
|
|
|
1075/15
|
07/09/2015
|
bortezomib (Velcade)
|
Full
|
In combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation
|
|
|
972/14
|
08/12/2014
|
pomalidomide (Imnovid)
|
Resubmission
|
in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
|
|
|
441/08
|
07/04/2014
|
lenalidomide (Revlimid)
|
Resubmission
|
In combination with dexamethasone, for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. (This resubmission relates to patients who have received only one prior therapy).
|
|
|
927/13
|
13/01/2014
|
bortezomib (Velcade)
|
Full
|
In combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
|
|
|
822/12
|
10/12/2012
|
bortezomib (Velcade)
|
Abbreviated
|
For the treatment of multiple meyeloma (2 indications).
|
|
|
700/11
|
11/04/2011
|
bendamustine (Levact)
|
Non submission
|
for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
|
|
