Selected EMA news

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

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)