Selected EMA news

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

October, 2021

Positive CHMP opinions on new medicines

  •  Brukinsa (zanubrutinib) - Orphan medicine
     Treatment of Waldenström’s macroglobulinaemia

September, 2021

New medicine authorised

  • Evrenzo (roxadustat)
    Treatment of anaemia symptoms (low red blood cell counts) caused by chronic kidney failure

August, 2021

Positive CHMP opinions on new medicines

  • Imatinib Koanaa (imatinib)
    Treatment of leukaemia and gastrointestinal stromal tumours

New information on authorised medicines

  • Ultomiris (ravulizumab) - extension of indication
    Treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome

Negative CHMP opinions on extension of indication

  • Siklos (hydroxycarbamide)
    Intended to extend the use of Siklos to include the treatment of severe chronic (long-term)
    anaemia in patients suffering from sickle cell syndrome

Safety update

  • Review of Zynteglo (betibeglogene autotemcel) - CHMP Opinion
    Treatment of beta thalassaemia

July, 2021

Positive CHMP opinions on new medicines

  • Evrenzo (roxadustat)
    Treatment of anaemia symptoms in patients with chronic kidney disease

New medicines authorised

  • Inrebic (fedratinib) Orphan Medicine
    Treatment of myelofibrosis
  • Onureg (azacitidine)
    Treatment of acute myeloid leukaemia

 

April, 2021

Positive CHMP opinions on new medicines

  • Copiktra (duvelisib)
    Treatment of relapsed or refractory chronic lymphocytic leukaemia and refractory follicular lymphoma

New medicines authorised

Negative CHMP opinions on new medicines

Withdrawal of applications to change the marketing authorisation

Safety update

March, 2021

Positive CHMP opinions on new medicines

  • Nexpovio (selinexor)
    Treatment of multiple myeloma (cancer of the bone marrow)
  • Thiotepa Riemser (thiotepa) generic of Tepadina
    Treatment prior to blood-stem cell transplantation

New medicines authorised

  • Lenalidomide KrKa (lenalidomide) generic of Revlimid
    Treatment of multiple myeloma and follicular lymphoma (blood cancers)
  • Lenalidomide KrKa d.d. (lenalidomide) generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma (blood cancers)
  • Lenalidomide KrKa d.d. Novo mesto (lenalidomide) generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma (blood cancers)

New information on authorised medicines

  • Sarclisa (isatuximab) - extension of indication
    Treatment of multiple myeloma (blood cancer)

Withdrawal of authorised medicines

  • Udenyca (pegfilgrastim)
    Treatment of neutropenia (low level of white blood cells)

Other information

Direct Healthcare Professional Communication (DHPC)

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)