Selected EMA news
Monthly news on EMA Scientific Committees decisions and updates on hematological medicines.
EMA News April 2022
Positive CHMP opinions on new medicines
- Carvykti (ciltacabtagene autoleucel) – Conditional approval
Treatment of multiple myeloma
- Zolsketil pegylated liposomal (doxorubicin)
Treatment of breast and ovarian cancers, multiple myeloma and AIDS-related Kaposi's sarcoma
New medicines authorised
- Dasatinib Accord and Dasatinib Accordpharma (dasatinib) - Generic of Sprycel
Treatment of leukemia - Oxbryta (Voxelotor) – Orphan medicine
Treatment of haemolytic anaemia in patients with sickle cell disease
New information on authorised medicines
- Kymriah (tisagenlecleucel) – Orphan medicine
New indication: Treatment of follicular lymphoma
- Polivy (polatuzumab vedotin) – Orphan medicine
New indication Treatment of large B-cell lymphoma
Withdrawal of applications for extension of indication
- Vyxeos liposomal (daunorubicin / cytarabine) – Orphan medicine
Intended for the treatment of patients aged 1 to 21 years with acute myeloid leukaemia
March, 2022
Positive CHMP opinions on new medicines
-
Carvykti (ciltacabtagene autoleucel)
Treatment of adult patients with relapsed and refractory multiple myeloma
New medicines authorised
- Evrenzo (roxadustat)
Treatment of the symptoms of anaemia caused by chronic kidney failure - Rivaroxaban Mylan (rivaroxaban) - generic of Xarelto
Treatment that prevents blood clotting
February, 2022
Positive CHMP opinions on new medicines
- Breyanzi (lisocabtagene maraleucel) – Orphan medicine
Treatment of lymphoma - Dasatinib Accord (dasatinib) – Generic of Sprycel
Treatment of leukemia - Dasatinib Accordpharma (dasatinib) – Generic of Sprycel
Treatment of leukemia - Stimufend (pegfilgrastim) – Biosimilar of Neulasta
Treatment of neutropenia after chemotherapy
New information on authorised medicines
- Ayvakyt (avapritinib) – Orphan medicine
New indication Treatment of gastrointestinal stromal tumour and systemic mastocytosis
Withdrawal of applications for new medicines
- Aliqopa (copanlisib)Treatment of previously treated marginal zone lymphoma
January, 2022
Positive CHMP opinions on new medicines
- Oxbryta (Voxelotor) - Orphan Medicine
Treatment of anemia due to sickle cell disease
New medicines authorised
- Aspaveli (pegcetacoplan) - Orphan Medicine
Treatment of paroxysmal nocturnal haemoglobinuria
December, 2021
Positive CHMP opinions on new medicines
- Tavneos (avacopan) - Orphan Medicine
Treatment of granulomatosis with polyangiitis or microscopic polyangiitis
November, 2021
Positive CHMP opinions on new medicines
- Aspaveli (pegcetacoplan)
Treatment of paroxysmal nocturnal haemoglobinuria
New medicines authorised
- Imatinib Koanaa (imatinib) generic of Glivec
Treatment of blood cancers and gastrointestinal stromal tumors
New information on authorised medicines
- Hizentra (human normal immunoglobulin (SCIg) - Extension of indication
Treatment of immunologic deficiency syndromes
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
- Inrebic (fedratinib) – Orphan Medicine
Treatment of myelofibrosis
Negative CHMP opinions on new medicines
- Gamifant (emapalumab)
Intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH)
Withdrawal of applications to change the marketing authorisation
- Brilique (ticagrelor)
Intended to be used with aspirin to prevent problems caused by blood clots
Safety update
- Review of Zynteglo (betibeglogene autotemcel) - review started (Art. 20)
Treatment of a blood disorder known as beta thalassaemia
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
- Precautionary marketing suspension of thalassaemia medicine Zynteglo (betibeglogene autotemcel)
Direct Healthcare Professional Communication (DHPC)
- Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to
avoid use in pregnancy
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
- Direct healthcare professional communication: Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
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)
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