Hematology

ALL

• ARI-0001

• Blinatumomab

  • Extension of indication to include treatment as part of consolidation therapy for the treatment of patients with Philadelphia chromosome negative CD19 positive B-cell precursor ALL
  • 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).
• Crisantaspase

• Dasatinib

  • Geïndiceerd voor de behandeling van volwassen patiënten met: nieuw gediagnosticeerde Philadelphiachromosoom-positieve (Ph+) chronische myeloïde leukemie (CML) in de chronische fase. CML in de chronische, acceleratie- of blastaire fase, die resistent of intolerant zijn voor eerder toegediende geneesmiddelen inclusief imatinib. Ph+ acute lymfoblastaire leukemie (ALL) en lymfoïde blasten CML die resistent of intolerant zijn voor eerder toegediende geneesmiddelen. Ook geïndiceerd voor de behandeling van pediatrische patiënten met: nieuw gediagnosticeerde Ph+ CML in de chronische fase (Ph+ CML-CP) of met Ph+ CML-CP die resistent of intolerant zijn voor eerder toegediende geneesmiddelen waaronder imatinib. Nieuw gediagnosticeerde Ph+ ALL in combinatie met chemotherapie.
• Inotuzumab ozogamicine ^IND
• Obecabtagene autoleucel

• Ponatinib

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

AML / MDS

• Azacitidine

  • Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).

• Cytarabine / daunorubicin (liposomaal)

  • Extension of indication to add treatment of relapsed/refractory AML in paediatric patients

• Decitabine / cedazuridine

  • Inaqovi is indicated as monotherapy for the 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).
  • Extension of indication to include treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
• Eprenetapopt
• 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)

• Gilteritinib

  • A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML).
• Glasdegib
• Imetelstat
• Iodine (131I) apamistamab

• Ivosidenib

  • Tibsovo in combinatie met azacitidine is geïndiceerd voor de behandeling van volwassen patiënten met nieuw gediagnosticeerde acute myeloïde leukemie (AML) met een R132-mutatie in isocitraatdehydrogenase-1 (IDH1), die niet in aanmerking komen voor standaard inductiechemotherapie.

• Luspatercept

  • Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS)
• Magrolimab
• Olutasidenib

• Quizartinib

  • Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
• Revumenib
• Tamibarotene

• Venetoclax

  • Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
• Ziftomenib

Aggressive non-Hodgkin’s lymphoma

• Acalabrutinib

  • 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.
  • 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).

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with diffuse large B‑cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

• Brentuximab vedotin

  • Extension of indication for ADCETRIS to include treatment for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone.
  • Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

• Brexucabtagene autoleucel

  • Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

• Crizotinib

  • Treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)‑positive anaplastic large cell lymphoma (ALCL) and the treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)‑positive unresectable inflammatory myofibroblastic tumour (IMT).
  • Extension of indication to include treatment of paediatric patients (age ≥ 6 to < 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumour (IMT)

• 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).
  • Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL), after two or more lines of systemic therapy.

• 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)
  • Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation

• Lisocabtagene maraleucel

  • Breyanzi voor de behandeling van recidief of refractair grootcellig B-cellymfoom (R/R DLBCL), primair mediastinaal B-cellymfoom (PMBCL), en folliculair lymfoom graad 3B (FL3B), na twee of meer lijnen systemische therapie
  • Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

• Loncastuximab tesirine

  • Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
  • 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.
• Odronextamab

• Pirtobrutinib

  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
  • Pirtobrutinib monotherapie voor de tweedelijns of latere behandeling van mantelcellymfoom bij volwassenen en ouderen die nog geen BTK-remmer hebben gebruikt.

• Polatuzumab vedotin

  • Polivy in combinatie met rituximab, cyclofosfamide, doxorubicine en prednison (R-CHP) is geïndiceerd voor de behandeling van volwassen patiënten met niet eerder behandeld diffuus grootcellig B-cellymfoom (DLBCL).
• Sonrotoclax
• Soquelitinib

• Tafasitamab

  • MINJUVI is indicated in combination with lenalidomide followed by MINJUVI 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).
  • 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).

• Zanubrutinib

  • Mantle-cell lymphoma (1L) + Rituximab.

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).
  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed/refractory CLL (chronic lymphocytic leukemia).
  • Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
• Duvelisib

• Ibrutinib

  • Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax 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.

• Ublituximab

  • In combination with umbralisib in patients with untreated and previously treated Chronic Lymphocytic Leukemia.

• Zanubrutinib

  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL).
  • Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy

CML

• Asciminib

  • Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP)
  • 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) previously treated with two or more tyrosine kinase inhibitors.

• 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

• Ruxolitinib

  • Extension of indication for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies and for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.

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)
  • ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).

• 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.

Indolent non-Hodgkin’s lymphoma

• 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.
• Copanlisib

• 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
• Hypericin

• Ibrutinib

  • Follicular lymphoma (FL), relapsed / refractory.

• Lisocabtagene maraleucel

  • 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.
  • 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.
  • 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.

• Mosunetuzumab

  • Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
  • 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.
• Parsaclisib

• 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.

• 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.
• Umbralisib

• Zanubrutinib

  • Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Multiple Myeloma

• Belantamab mafodotin

  • Multiple Myeloma 3L
  • Second line treatment of r/r multiple myeloma in adults and elderly, in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone.

• Carfilzomib

  • 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.

• Ciltacabtagene autoleucel

  • CARVYKTI is geïndiceerd voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom, die minimaal drie eerdere behandelingen hebben gekregen, waaronder een immunomodulerend middel, een proteasoomremmer en een anti-CD38-antilichaam en die tijdens de laatste therapie ziekteprogressie hebben vertoond.
  • 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 to extend the existing therapeutic indication for daratumumab 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 (ASCT).
  • 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).
  • Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
  • In combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
  • 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.
  • Extension of indication to extend the existing therapeutic indication for daratumumab in combination with lenalidomide and dexamethasone (Rd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

• Elranatamab

  • 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.
  • 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

  • Abecma is indicated 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.
  • 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

  • Sarclisa is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  • 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.
  • 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.

• Ixazomib

  • Non-ASCT maintenance  Multiple Myeloma (MM)
• Linvoseltamab

• Melphalan flufenamide

  • Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior lines of therapies, whose disease is refractory to lenalidomide and the last line of therapy.
  • Pepaxti, in combinatie met dexamethason, is geïndiceerd voor de behandeling van volwassen patiënten met multipel myeloom die minstens drie eerdere therapielijnen hebben gekregen, bij wie de ziekte refractair is voor ten minste één proteasoomremmer, één immunomodulerend middel, één antiCD38-monoklonaal antilichaam, en die tijdens of na hun laatste therapie ziekteprogressie vertoonden. Bij patiënten die eerder een autologe stamceltransplantatie hebben ondergaan, moet er tussen die transplantatie en de progressie ten minste drie jaar zijn verstreken.

• 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.

• Pomalidomide

  • Treatment of adult patients with relapsed and refractory multiple myeloma in combination with dexamethasone
  • Extension of indication to include treatment with Imnovid in combination with bortezomib and dexamethasone of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

• 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.
  • Patients With Relapsed or Refractory Multiple Myeloma (4L).
  • 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

  • Tecvayli 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.
  • 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.
• Thalidomide ^G

• Venetoclax

  • Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
• Zevorcabtagene autoleucel

Myeloproliferative disorders

• Avapritinib

  • Advanced systemic mastocytosis (AdvSM). AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.

• Givinostat

  • Givinostat monotherapy for treatment of high-risk JAK2V617F-positive polycythaemia vera in adults and elderly.
• Momelotinib
• Navitoclax
• Peginterferon alfa-2a ^IND
• Pelabresib

• Pemigatinib

  • Extension of indication to include treatment of adults with myeloid/lymphoid neoplasms (MLNs) with Fibroblast Growth Factor Receptor1 (FGFR1) rearrangement.
• Ropeginterferon alfa-2b

Other hematology

• Lenzilumab

• Obinutuzumab

  • Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro.
• Sargramostim

• Zanubrutinib

  • Patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy.

Stem cell transplants

• Abatacept

  • Extension of indication to include the prophylaxis of acute Graft versus Host Disease (aGvHD) in the adult and paediatric population for Orencia.
• Dorocubicel
• Etuvetidigene autotemcel
• Inolimomab
• Motixafortide
• Narsoplimab
• Nomacopan
• Omidubicel

• Plerixafor

  • Multiple Myeloma; Hematopoietic Stem Cell Transplantation

• Ruxolitinib

  • Extension of indication to include treatment of patients with GvHD aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies for Jakavi.
• Tabelecleucel

• Treosulfan

  • Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients, and in paediatric patients older than one month with malignant and non‑malignant diseases.

Unknown

• Axicabtagene ciloleucel

  • Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL)

Unknown

• 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.