Multiple myeloma
The EU has approved 39 indications of 18 drugs in multiple myeloma. None of them needs a biomarker result.
Stage
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| No biomarker required39 | ||||
Velcade | None | + dexamethasone, or with dexamethasone and thalidomide | Induction | Eligible for high-dose chemotherapy with haematopoietic stem cell transplantation |
Velcade | None | + melphalan and prednisone | 1L | Ineligible for high-dose chemotherapy with haematopoietic stem cell transplantation |
Darzalex | None | + bortezomib, lenalidomide and dexamethasone | 1L | None |
Darzalex | None | + bortezomib, thalidomide and dexamethasone | 1L | Eligible for autologous stem cell transplant |
Darzalex | None | + lenalidomide and dexamethasone, or bortezomib, melphalan and prednisone | 1L | Ineligible for autologous stem cell transplant |
Sarclisa | None | + bortezomib, lenalidomide, and dexamethasone | 1L | Transplant-ineligible |
Sarclisa | None | + bortezomib, lenalidomide, and dexamethasone | Induction | Transplant-eligible |
Revlimid | None | + dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone | 1L | Transplant-ineligible |
Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed | None | + melphalan and prednisone | 1L | Aged ≥ 65 years or ineligible for high dose chemotherapy |
Revlimid | None | Monotherapy | Maint. | After autologous stem cell transplantation |
Blenrep | None | + bortezomib and dexamethasone | 2L | After at least one prior therapy; Relapsed or refractory |
Blenrep | None | + pomalidomide and dexamethasone | 2L | After at least one prior therapy including lenalidomide; Relapsed or refractory |
Velcade | None | + pegylated liposomal doxorubicin or dexamethasone | 2L | After at least 1 prior therapy; Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation |
Velcade | None | Monotherapy | 2L | After at least 1 prior therapy; Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation |
Kyprolis | None | + daratumumab and dexamethasone | 2L | After at least one prior therapy |
Kyprolis | None | + dexamethasone | 2L | After at least one prior therapy |
Kyprolis | None | + lenalidomide and dexamethasone | 2L | After at least one prior therapy |
Carvykti | None | Monotherapy | 2L | After at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor; disease progression on the last therapy; refractory to lenalidomide |
Darzalex | None | + lenalidomide and dexamethasone, or bortezomib and dexamethasone | 2L | After at least one prior therapy |
Darzalex | None | + pomalidomide and dexamethasone | 2L | After one prior therapy containing a proteasome inhibitor and lenalidomide with lenalidomide refractoriness, or at least two prior therapies including lenalidomide and a proteasome inhibitor with disease progression on or after the last therapy |
Darzalex | None | Monotherapy | 2L | After prior therapy included a proteasome inhibitor and an immunomodulatory agent, and demonstrated disease progression on the last therapy |
Empliciti | None | + lenalidomide and dexamethasone | 2L | After at least one prior therapy |
Sarclisa | None | + carfilzomib and dexamethasone | 2L | After at least one prior therapy |
Ninlaro | None | + lenalidomide and dexamethasone | 2L | After at least one prior therapy |
Revlimid | None | + dexamethasone | 2L | After at least one prior therapy |
Imnovid (previously Pomalidomide Celgene) | None | + bortezomib and dexamethasone | 2L | After at least one prior treatment regimen including lenalidomide |
Nexpovio | None | + bortezomib and dexamethasone | 2L | After at least one prior therapy |
Tecvayli | None | + daratumumab | 2L | After at least one prior therapy; Relapsed or refractory |
Empliciti | None | + pomalidomide and dexamethasone | 3L+ | After at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy |
Elrexfioconditional | None | Monotherapy | 3L+ | After at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and demonstrated disease progression on the last therapy |
Abecma | None | Monotherapy | 3L+ | After at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, with disease progression on the last therapy |
Sarclisa | None | + pomalidomide and dexamethasone | 3L+ | After at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy |
Lynozyficconditional | 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 |
Farydak | None | + bortezomib and dexamethasone | 3L+ | After at least two prior regimens including bortezomib and an immunomodulatory agent |
Imnovid (previously Pomalidomide Celgene) | None | + dexamethasone | 3L+ | After at least two prior treatment regimens, including both lenalidomide and bortezomib, and disease progression on the last therapy; Relapsed and refractory |
Nexpovio | None | + dexamethasone | 3L+ | After at least four prior therapies; refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, with disease progression on the last therapy |
Talveyconditional | 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 |
Tecvayli | None | Monotherapy | 3L+ | After at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody; disease progression on the last therapy; Relapsed and refractory |
Darzalex | None | Monotherapy | Any line | Smouldering myeloma only (high risk); High risk of developing multiple myeloma |
Label wording39
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Ciltacabtagene autoleucel (Carvykti)
CARVYKTI is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
- Pomalidomide (Imnovid (previously Pomalidomide Celgene))
Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
- Pomalidomide (Imnovid (previously Pomalidomide Celgene))
Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
- Teclistamab (Tecvayli)
in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
- Teclistamab (Tecvayli)
as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
- Belantamab mafodotin (Blenrep)
in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
- Belantamab mafodotin (Blenrep)
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
- Daratumumab (Darzalex)
in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- Daratumumab (Darzalex)
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.
- Daratumumab (Darzalex)
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.
- Daratumumab (Darzalex)
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.
- Daratumumab (Darzalex)
in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.
- Daratumumab (Darzalex)
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 (see section 5.1).
- Daratumumab (Darzalex)
DARZALEX as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma (see section 5.1).
- Ixazomib (Ninlaro)
NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
- Selinexor (Nexpovio)
in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
- Selinexor (Nexpovio)
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.
- Carfilzomib (Kyprolis)
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
- Carfilzomib (Kyprolis)
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
- Carfilzomib (Kyprolis)
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
- Isatuximab (Sarclisa)
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.
- Isatuximab (Sarclisa)
in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
- Isatuximab (Sarclisa)
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.
- Isatuximab (Sarclisa)
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.
- Lenalidomide (Revlimid)
Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
- Lenalidomide (Revlimid)
Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
- Lenalidomide (Revlimid)
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
- Bortezomib (Velcade)
VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
- Bortezomib (Velcade)
VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
- Bortezomib (Velcade)
VELCADE in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
- Bortezomib (Velcade)
VELCADE in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
- Elranatamab (Elrexfio)
ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
- Idecabtagene vicleucel (Abecma)
Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
- Talquetamab (Talvey)
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.
- Panobinostat (Farydak)
Farydak, in combination with bortezomib and dexamethasone, is indicated 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.
- Elotuzumab (Empliciti)
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).
- Elotuzumab (Empliciti)
Empliciti is indicated 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 (see sections 4.2 and 5.1).
- Thalidomide (Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed)
Thalidomide BMS in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.
- Linvoseltamab (Lynozyfic)
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.