Hematologie

ALL

• ARI-0001

• Blinatumomab

  • Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor 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

  • Extension of indication to include treatment of adult patients with newly-diagnosed Ph+ ALL.

AML/MDS

• Decitabine / cedazuridine

  • Extension of indication to include treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
  • Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
• Galinpepimut-S

• Gemtuzumab ozogamicin

  • Extension of indication to include, 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
• Olutasidenib
• Revumenib
• Ziftomenib

CLL

• Acalabrutinib

  • Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
• 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.

CML

• Asciminib

  • Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) harbouring the T315I mutation.
  • Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP)

• 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

  • Extension of Indication to include treatment of paediatric patients aged 6 years and older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant or intolerant to at least one tyrosine kinase inhibitor

Graft versus Host

• Belumosudil
• MaaT013

Hematologie, overig

• Sargramostim

Hodgkin lymfoom

• 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

  • Extension of indication for OPDIVO to include treatment of patients paediatric and adults, with relapsed/refractory classical Hodgkin Lymphoma in combination with brentuximab vedotin.
  • Extension of indication to include OPDIVO for the treatment of adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL)

• Tislelizumab

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

Multipel Myeloom

• 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

  • Extension of indication for Darzalex in combination with bortezomib, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma, to include also adult patients who are not eligible for stem cell transplant (SCT).
  • 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).

• Elranatamab

  • 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.
  • Elrexfio is geïndiceerd voor volwassen patiënten met gerecidiveerd en refractair multipel myeloom, die ten minste 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.
  • Elranatamab monotherapy for relapsed/refractory multiple myeloma patients who have received anti CD38 directed therapy and lenalidomide.
• 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

  • 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.
  • 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.
  • 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.
• Linvoseltamab

• Mezigdomide

  • 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.
  • 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.

• Selinexor

  • In combinatie met bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die tenminste één eerdere therapie hebben ondergaan.

• 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 proteasoom-remmer en een antiCD38antilichaam. En die tijdens de laatste therapie ziekteprogressie hebben vertoond.
  • 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.
  • 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 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.

• Teclistamab

  • 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.

Myeloproliferatieve aandoeningen

• Givinostat

  • Givinostat monotherapy for treatment of high-risk JAK2V617F-positive polycythaemia vera in adults and elderly.
• Navitoclax

Non-hodgkin lymfoom agressief

• 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.

• Epcoritamab

  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

• Glofitamab

  • Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).

• 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
• Soquelitinib

• 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 grootcellig B-cellymfoom (DLBCL).

Non-hodgkin lymfoom indolent

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

• 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.
  • 2L Follicular Lymphoma

• 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.

• Mosunetuzumab

  • Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refractory CD20+ (grades 1-3a) follicular lymphoma in adults and elderly who have received at least one line of prior systemic therapy.

• Tafasitamab

  • Minjuvi 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.

Stamceltransplantaties

• Dorocubicel
• Etuvetidigene autotemcel
• Narsoplimab
• Nomacopan

Onbekend

• Luspatercept

  • Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia Extension of indication in β-thalassaemia to include adult patients with non-transfusion dependent β-thalassaemia (NTDT).

• Talquetamab

  • 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.