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Melphalan flufenamide (multiple myeloma, ≥ 3 prior therapies, in combination with dexamethasone)

 

Subject:

  • Active Substance: Melphalan flufenamide 
  • Name: Pepaxti®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Oncopeptides AB

 

Time table:

  • Start: 01.10.2022
  • Publication of assessment: 02.01.2023
  • End of public hearing: 23.01.2023
  • Final decision by G-BA: middle of March 2023

 

Comparative therapy:

  • A patient-individual therapy taking into account prior therapies as well as degree and duration of response to treatment, choosing from:
    • Bortezomib monotherapy
    • Bortezomib + pegylated liposomal doxorubicin
    • Bortezomib + dexamethasone
    • Carfilzomib + lenalidomide + dexamethasone
    • Carfilzomib + dexamethasone 
    • Daratumumab + lenalidomide + dexamethasone 
    • Daratumumab + bortezomib + dexamethasone
    • Daratumumab monotherapy (only for patients with disease progression on the previous therapy)
    • Elotuzumab + lenalidomide + dexamethasone
    • Elotuzumab + pomalidomide + dexamethasone (only for patients with disease progression on the previous therapy)
    • Isatuximab + pomalidomide + dexamethasone (only for patients with disease progression on the previous therapy)
    • Ixazomib + lenalidomide + dexamethasone
    • Lenalidomide + dexamethasone
    • Panobinostat + bortezomib and dexamethasone
    • Pomalidomide + bortezomib and  dexamethasone
    • Pomalidomide + dexamethasone (only for patients with disease progression on the previous therapy)
    • Cyclophosphamide (in combination with additional antineoplastic drugs)
    • Melphalan
    • Doxorubicin
    • Carmustine (in combination with other cytostatics and an adrenal cortex hormone, especially prednisone)
    • Vincristine
    • Dexamethasone
    • Prednisolone
    • Prednisone
    • Best supportive care