Hematology

ALL

• Brexucabtagene autoleucel

  • Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
• Inotuzumab ozogamicine ^IND
• Obecabtagene autoleucel

• Ponatinib

  • Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).

AML / MDS

• Decitabine / cedazuridine

  • Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
• Galinpepimut-S

• Gemtuzumab ozogamicin

  • In combination with mitoxantrone and cytarabine (AraC), the treatment of paediatric patients aged 1 year to less than 18 years with newly diagnosed CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
• Imetelstat
• Revumenib

• Venetoclax

  • Newly diagnosed high-risk myelodysplastic syndrome in adults and elderly.
• Ziftomenib

Aggressive non-Hodgkin’s lymphoma

• Acalabrutinib

  • Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).
  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.
  • diffuse large B-cell lymphoma (based on study ESCALADE- ACE-LY-312)); Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL.

• Brentuximab vedotin

  • Brentuximab vedotin in combination with lenalidomide and rituximab for third line or later treatment of relapsed or refractory Diffuse large B-cell lymphoma in adults and elderly ineligible for haematopoietic stem cell transplantation or CAR-T therapy.

• Epcoritamab

  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • 1L Diffuse Large B-Cell Lymphoma (E + R-CHOP)
  • 2L Diffuse Large B-Cell Lymphoma`(E + len)

• Ibrutinib

  • Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).

• Loncastuximab tesirine

  • Loncastuximab tesirine in combination with rituximab for second line or later treatment of relapsed or refractory Diffuse large B-cell lymphoma in adults and elderly who are ineligible for stem cell transplantation.

• Pirtobrutinib

  • Pirtobrutinib monotherapie voor de tweedelijns of latere behandeling van mantelcellymfoom bij volwassenen en ouderen die nog geen BTK-remmer hebben gebruikt.
• Sonrotoclax

• Tafasitamab

  • Tafasitamab in combinatie met lenalidomide is geïndiceerd in combinatie met rituximab, cyclofosfamide, doxorubicine, vincristine en prednison (R-CHOP) voor de behandeling van volwassen patiënten met onbehandeld diffuus groot cellig B-cellymfoom (DLBCL).

• Zamtocabtagene autoleucel

  • Treatment of adults with large B-cell lymphoma
  • Zamtocabtagene autoleucel monotherapy for third line or later treatment of relapsed/refractory Diffuse large B-cell lymphoma in adults and elderly who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

CLL

• Bgb-16673

  • Second line treatment of relapsed or refractory Chronic lymphocytic leukaemia in adults and elderly previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
• Nemtabrutinib

• Pirtobrutinib

  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have been previously treated with a BTK inhibitor.
  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL).

• Venetoclax

  • Extension of indication to include, in combination with ibrutinib, the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Extension of indication to include, in combination with acalabrutinib with or without obinutuzumab, the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

CML

• Asciminib

  • Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP).
  • Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib.

• Bosutinib

  • Paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). Paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

• Ponatinib

  • Treatment of chronic myeloid leukaemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults.
  • Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Graft versus Host

• Belumosudil
• Cyp-001
• MaaT013

Hodgkin's lymphoma

• Brentuximab vedotin

  • Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage 3 or Stage 4 HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1)

• Nivolumab

  • Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma
  • Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.

• Pembrolizumab

  • Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

• Tislelizumab

  • Tislelizumab monotherapy for third line, salvage treatment of relapsed or refractory classical Hodgkin lymphoma in adults and elderly.

Indolent non-Hodgkin’s lymphoma

• Epcoritamab

  • Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

• Lisocabtagene maraleucel

  • Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
  • Lisocabtagene maraleucel is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant.
• Orelabrutinib

• Tafasitamab

  • Tafasitamab in combinatie met lenalidomide en rituximab voor de behandeling van volwassen patiënten met een gerecidiveerd of refractair folliculair lymfoom (FL) (graad 1-3a) na tenminste één eerdere systemische behandeling.

• Tisagenlecleucel-T

  • Extension of indication for Kymriah, to include adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Multiple Myeloma

• Belantamab mafodotin

  • Second line treatment of r/r multiple myeloma in adults and elderly, in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone.

• Ciltacabtagene autoleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 1 prior therapy, including an IMiD and a PI, have demonstrated disease progression on or after the last therapy and are refractory to lenalidomide.

• Daratumumab

  • Daratumumab in combination with lenalidomide for maintenance treatment of newly diagnosed Multiple myeloma in adults and elderly who are minimal residual disease positive after frontline autologous stem cell transplant.

• Elranatamab

  • Monotherapy for relapsed/refractory multiple myeloma patients who have received anti CD38 directed therapy and lenalidomide.
  • Voor volwassen patiënten met gerecidiveerd en refractair multipel myeloom, die tenminste drie eerdere behandelingen hebben gekregen, waaronder een immuno modulator, een proteasoom remmer en een anti CD38 antilichaam en die tijdens de laatste behandeling ziekteprogressie hebben vertoond.
  • Monotherapy for the treatment of patients with relapsed and refractory multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor, and an immunomodulatory agent.
• Iberdomide

• Idecabtagene vicleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.

• Isatuximab

  • 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.
  • Extension of indication to include 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 subcutaan in combinatie met pomalidomide en dexamethason voor de behandeling van volwassen patiënten met gerecidiveerd en refractair multipel myeloom (MM) die minstens twee eerdere therapieën hebben gekregen, waaronder lenalidomide en een proteasoomremmer (maar niet refractair zijn op daratumumab) en bij wie ziekteprogressie is aangetoond tijdens de laatste behandeling.
• Linvoseltamab

• Mezigdomide

  • Mezigdomide in combination with carfilzomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have received prior treatments with lenalidomide and an anti-CD38 monoclonal antibody.
  • Mezigdomide in combination with bortezomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have had prior lenalidomide exposure.

• Talquetamab

  • Talquetamab is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom die minimaal drie eerdere behandelingen hebben gekregen, waaronder een immuno-modulerend middel een proteasoomremmer en een antiCD38antilichaam. En die tijdens de laatste therapie ziekteprogressie hebben vertoond.
  • Talquetamab in combination with pomalidomide and dexamethasone for second line or later treatment of Relapsed/refractory multiple myeloma in adults and elderly who have received an anti-CD38 antibody and lenalidomide.
  • Talquetamab in combination with daratumumab and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide.
  • Talquetamab in combination with daratumumab, pomalidomide and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide.
  • Talquetamab in combination with teclistamab and dexamethasone for second line or later treatment of Relapsed/refractory multiple myeloma in adults and elderly who have received an anti-CD38 antibody and lenalidomide.

• Teclistamab

  • Teclistamab in combination with daratumumab for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who have previously received a proteasome inhibitor and lenalidomide.
  • Teclistamab monotherapy for second line or later treatment of progressive, relapsed or refractory Multiple myeloma in adults and elderly who have received an anti-CD38 monoclonal antibody and lenalidomide in any previous line.

Myeloproliferative disorders

• Bomedemstat

• Givinostat

  • Givinostat monotherapy for treatment of high-risk JAK2V617F-positive polycythaemia vera in adults and elderly.
• Pacritinib
• Pelabresib
• Pivekimab Sunirine

Other hematology

• BGB-16673

  • Treatment of Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor

• Iopofosine I 131

  • Iopofosine i 131 monotherapy for third line or later treatment of relapsed or refractory Waldenstromʼs macroglobulinaemia in adults and elderly.
• Sargramostim

Stem cell transplants

• Dorocubicel
• Etuvetidigene autotemcel
• Narsoplimab