Selected EMA news

Monthly news on EMA Scientific Committees decisions and updates on hematological medicines.

February, 2021

New medicines authorised

  • Elzonris (tagraxofusp) Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
  • Tecartus (Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured) Treatment of mantle cell lymphoma – Orphan Medicine

January, 2021

Positive CHMP opinions on new medicines

  • Inrebic (fedratinib) – Orphan Medicine
    Treatment of of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
  • Lenalidomide KrKa (lenalidomide) - generic of Revlimid
    Treatment of multiple myeloma and follicular lymphoma
  • Lenalidomide KrKa d.d. (lenalidomide) - generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma
  • Lenalidomide KrKa d.d. Novo mesto (lenalidomide) - generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma
  • Lumoxiti (moxetumomab pasudotox)
    Treatment of relapsed or refractory hairy cell leukaemia – Orphan Medicine, Exceptional Circumstances

New information on authorised medicines

  • Nplate (romiplostim) - extension of indication
    Treatment of patients with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys platelets

New information on authorised medicines

  • Doptelet (avatrombopag) - new indication Treatment of severe thrombocytopenia in patients with chronic liver disease

December, 2020

Positive CHMP opinions on new medicines-following re-examination

  • Elzonris (tagraxofusp) Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) – Exceptional Circumstances

New medicines authorised

  • Adakveo (crizanlizumab) Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
  • Calquence (acalabrutinib) Treatment of chronic lymphocytic leukaemia – Orphan medicine
  • Nyvepria (pegfilgrastim) Treatment of neutropenia in cancer patients - Biosimilar of Neulasta
  • Phelinun (melphalan ) Treatment of blood and bone marrow cancers and preparing patients for blood stem cell transplants
  • Rivaroxaban Accord (rivaroxaban) Treatment and prevention of blood clots - Generic

New information on authorised medicines

  • Kyprolis (carfilzomib) - extension of indication Treatment of adult patients with multiple myeloma

Safety update


November, 2020

Positive CHMP opinions on new medicines

  • Lenalidomide Mylan (lenalidomide) - Generic
    Treatment of multiple myeloma and follicular lymphoma (blood cancers)

New medicines authorised

New information on authorised medicines

  • Blincyto (blinatumomab) - extension of indication – Orphan medicine
    Treatment of B-precursor acute lymphoblastic leukaemia (a type of blood cancer)

Safety update

October, 2020

  • Positive CHMP opinions on new medicines
    - Nyvepria (pegfilgrastim) - Biosimilar of Neulasta
    Treatment of neutropenia in cancer patients
    - Rivaroxaban Accord (rivaroxaban) - Generic
    Treatment and prevention of blood clots

  • New medicines authorised
    - Blenrep (belantamab mafodotin) – Conditional Approval – Orphan Medicine
    Treatment of multiple myeloma

  • Re-examination request following negative CHMP opinions on new medicines
    - Elzonris (tagraxofusp)
    Intended for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a
    rare and aggressive type of blood cancer

August, 2020

  • Positive CHMP opinions on new medicines
    - Adakveo (crizanlizumab)
    Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
    - Arsenic trioxide medac (arsenic trioxide)
    Treatment of acute promyelocytic leukaemia
    - Calquence (acalabrutinib) – Orphan Medicine
    Treatment of chronic lymphocytic leukaemia

  • New medicines authorised
    - Daurismo (glasdegib)
    Treatment of acute myeloid leukaemia (blood cancer)
    - Reblozyl (luspatercept) – Orphan Medicine
    Treatment of anaemia caused by myelodysplastic syndromes (MDS) or betathalassaemia

  • New information on authorised medicines
    - Crysvita (burosumab) - change and extension of indication – Orphan Medicine –
    Conditional Approval
    Treatment of X-linked hypophosphataemia
    - Imbruvica (ibrutinib) - extension of indication – Orphan Medicine
    Treatment of blood cancers
    - NovoThirteen (catridecacog)- extension of indication
    Prevention of bleeding in patients with inherited blood clotting disorder

  • Negative CHMP opinions on new medicines
    - Gamifant (emapalumab)
    Intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH)