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
- Arsenic trioxide medac (arsenic trioxide) - Generic
Treatment of acute promyelocytic leukaemia (blood cancer)
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
- Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
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)