Selected EMA news

October 2024

New medicines recommended for approval

  • Pomalidomide Teva (pomalidomide) – generic
    Treatment of multiple myeloma (a type of blood cancer)

  • Hympavzi (marstacimab) – orphan medicine
    Treatment of bleeding episodes

New information on approved medicines

  • Darzalex (daratumumab) – new indicationorphan medicine
    Treatment of multiple myeloma (a type of blood cancer)

  • Esperoct (turoctocog alfa pegol) – extension of indication
    Treatment and prevention of bleeding

Direct Healthcare Professional Communication (DHPC)

  • Oxbryta (voxelotor) - Suspension of EU marketing authorization
    Treatment of anaemia in patients with sickle cell disease

September 2024

Safety update

  • Withdrawal of Oxbryta (Voxelotor) – marketing authorization suspended
    Treatment of haemolytic anaemia (excessive breakdown of red blood cells) due to sickle cell disease

New medicines approved

  • Adzynma (rADAMTS13) - orphan medicine
    Treatment of congenital thrombotic thrombocytopenic purpura (an inherited clotting disorder)

Other EMA news

  • EMA's safety committee, PRAC, has recommended measures to minimize the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole.

August 2024

Safety update

  • Review of Oxbryta (Voxelotor) – review started
    Treatment of haemolytic anaemia (excessive breakdown of red blood cells) due to sickle cell disease

Direct Healthcare Professional Communication (DHPC)

July 2024

Positive CHMP opinions on new medicines

  • Nilotinib Accord (nilotinib) – generic
    Treatment of chronic myelogenous leukaemia (blood cancer)

  • Ordspono (odronextamab) – orphan medicine
    Treatment of different kind of blood cancers

  • Piasky (crovalimab)
    Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)

New medicines authorized

  • Fabhalta (Iptacopan) – orphan medicine
    Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells), thrombosis (blood clots in blood vessels), pancytopenia (low levels of blood cells) and dark urine (due to large amounts of haemoglobin being released into the urine)

New information on authorized medicines

  • Tepkinly (epcoritamab) – new indicationorphanconditional approval
    Treatment of lymphoma and large B-cell cancer (blood cancers)

  • Pegasys (peginterferon alfa-2a) – extension of indication
    Treatment of polycythaemia vera (blood disease leading to production of too many red blood cells), essential thrombocythaemia (too many platelets in the blood), chronic hepatitis B and C

Safety update

June 2024

Positive CHMP opinions on new medicines

  • Durveqtix (fidanacogene elaparvovec)
    Treatment of haemophilia B

  • Dasatinib Accord Healthcare (dasatinib) – generic of Sprycel
    Treatment of chronic myelogenous leukaemia, a type of blood cancer

  • Pomalidomide Accord (pomalidomide) – generic of Imnovid
    Treatment of multiple myeloma, cancer of the bone marrow

  • Pomalidomide Zentiva (pomalidomide) – generic of Imnovid
    Treatment of multiple myeloma, cancer of the bone marrow

Safety update

  • CAR T-cell medicines (Yescarta, Tecartus, Carvykti, Abecma, Breyanzi, Kymriah) - PRAC recommendation
    Personalized treatment for different types of blood cancer that uses a patient’s own white blood cells (T-cells) to attack the cancer

May 2024

Positive CHMP opinions on new medicines

  • Altuvoct (efanesoctocog alfa)
    Treatment and prevention of bleeding in patients with hemophilia A

April 2024

Positive CHMP opinions on new medicines

  • Fabhalta (iptacopan) – orphan medicine
    Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)

Withdrawal of applications for new medicines

  • Adcetris (brentuximab vedotin)
    Treatment of certain lymphomas (cancers of lymphocytes, types of white blood cells)

Supply shortages

  • Fludarabine
    Treatment of chronic lymphocytic leukaemia (type of blood cancer)

March 2024

Positive CHMP opinions on new medicines

  • Voydeya (danicopan) – orphan medicine
    Add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria, rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells (haemolytic anaemia) by the immune system

New information on authorized medicines

  • Carvykti (ciltacabtagene autoleucel) – orphan medicine – conditional approval – extension of indication
    Treatment of relapsed and refractory multiple myeloma (cancer of the bone marrow)

  • Reblozyl (luspatercept) – extension of indication
    Treatment of anaemia (low red blood cell counts)

  • Xromi (hydroxycarbamide) – extension of indication
    Treatment of sickle cell disease

Supply shortages

  • Eldisine (vindesine)
    Treatment of different types of blood cancers, such as acute lymphoblastic leukaemia and chemotherapy-refractory lymphoma, as well as certain solid tumours

February 2024

Positive CHMP opinions on new medicines

  • Ryzneuta (efbemalenograstim alfa)
    Treatment to reduce the duration of neutropenia (low level of white blood cells) and the incidence of febrile neutropenia due to chemotherapy

New information on authorized medicines

  • Aspaveli (pegcetacoplan) – orphan medicine – extension of indication
    Treatment of paroxysmal nocturnal haemoglobinuria (PNH), a condition in which there is excessive breakdown of red blood cells

  • Abecma (idecabtagene vicleucel) – orphan medicine – conditional approval – extension of indication
    Treatment of multiple myeloma (a cancer of the bone marrow)

January 2024

Positive CHMP opinions on new medicines

  • Casgevy (exagamglogene autotemcel) – orphan medicine – conditional approval
    Treatment of transfusion dependent β-thalassemia and sickle cell disease

  • Pomalidomide Viatris (pomalidomide) – generic of Imnovid
    Treatment of multiple myeloma

New information on authorized medicines

  • VeraSeal (human fibrinogen / human thrombin) – extension of indication
    Treatment for stopping bleeding during surgeries 

Negative CHMP opinions on renewal of authorized medicine

  • Blenrep (belantamab mafodotin
    Intended for treatment of multiple myeloma

November–December 2023

Positive CHMP opinions on new medicines

  • Elrexfio (elranatamab) – conditional approval
    Treatment of multiple myeloma

New medicines authorized

  • Enrylaze (crisantaspase)
    Treatment of lymphoblastic leukaemia and lymphoblastic lymphoma

  • Inaqovi (cedazuridine / decitabine)
    Treatment of myeloid leukaemia

  • Tepkinly (epcoritamab) – orphan medicine – conditional approval
    Treatment of blood cancer called diffuse large B-cell lymphoma

  • Vanflyta (quizartinib)
    Treatment of myeloid leukaemia

New information on authorized medicines

  • Veyvondi (vonicog alfa) – orphan medicine – extension of indication
    Treatment of von Willebrand disease

Special update, November 2023

Electronic Product Information (ePI) for selected human medicines published for first time

EMA, along with the Heads of Medicines Agencies (HMA) and the European Commission (EC) have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union.

This forms part of the ePI initiative, a one-year pilot by HMA, EMA, and the EC to enable the transition to an electronic system for medicines evaluated both nationally and at European level.

October 2023

Positive CHMP opinions on new medicines

  • Vanflyta (quizartinib) orphan medicine
    Treatment of acute myeloid leukaemia (blood cancer)
  • Elrexfio (elranatamab)orphan medicine – conditional approval
    Treatment of multiple myeloma (a type of white blood cell cancer)

New medicines authorized

  • Talvey (talquetamab)orphan medicine – conditional approval
    Treatment of multiple myeloma (a type of white blood cell cancer)

New information on authorized medicines

  • Adcetris (brentuximab vedotin) orphan medicineextension of indication
    Treatment of stage III Hodgkin lymphoma (a cancer of lymphocytes)

Withdrawal of authorized medicines

Withdrawal of applications for extension of indication

  • Iclusig (ponatinib)
    Intended for the treatment of adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia (blood cancer)

Negative CHMP opinions on renewal of conditional marketing authorization

September 2023

Direct Healthcare Professional Communication (DHPC)

August 2023

Positive CHMP opinions on new medicines

  • Enrylaze (crisantaspase)
    Treatment of acute lymphoblastic leukaemia (a type of blood cancer)
  • Inaqovi (cedazuridine / decitabine)orphan medicine
    Treatment of myeloid leukaemia (a type of blood cancer)
  • Talvey (talquetamab)orphan medicine – conditional approval
    Treatment of multiple myeloma, a type of white blood cell cancer
  • Tepkinly (epcoritamab) – conditional approval
    Treatment of large B-cell lymphoma (a type of blood cancer)

New medicines authorized

  • Columvi (glofitamab) orphan medicine
    Treatment of blood cancer called diffuse large B-cell lymphoma (a type of blood cancer)

Withdrawal of applications for extension of indication

  • Gazyvaro (obinutuzumab)
    Intended to prevent a serious side effect (cytokine release syndrome) that occurs with the blood cancer medicine Columvi

Withdrawal of applications for new medicines

  • Jesduvroq (daprodustat)
    Treatment of symptomatic anaemia in patients with chronic kidney disease

Direct Healthcare Professional Communication (DHPC)

July 2023

Positive CHMP opinions on new medicines

  • Jesduvroq (daprodustat)
    Treatment of anaemia in adults with chronic kidney disease

New information on authorized medicines

  • Mircera (methoxy polyethylene glycol-epoetin beta) - extension of indication
    Treatment of anaemia associated with chronic kidney disease in children
  • Refixia (nonacog beta pegol) - extension of indication
    Treatment of haemophilia B

Withdrawal of applications for new medicines

  • Dyrupeg (pegfilgrastim)
    Intended to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cells in cancer patients)
  • Zefylti (filgrastim)
    Intended to stimulate the production of white blood cells

Direct Healthcare Professional Communication (DHPC)

  • Adakveo (crizanlizumab) - orphan medicine
    Prevention of painful crises in patients with sickle cell disease

June 2023

New medicines authorized

  • Epysqli (Eculizumab)
    Treatment of paroxysmal nocturnal haemoglobinuria, a disease in which excessive breakdown of red blood cells results in various medical complications
  • Tibsovo (ivosidenib)
    Treatment of acute myeloid leukaemia (a blood cancer) and biliary tract cancer (cancer of the bile ducts)
  • Vafseo (vadadustat)
    Treatment of anaemia (low levels of red blood cells) associated with chronic kidney disease

Supply shortages

  • Actilyse (alteplase)
    Treatment of acute pulmonary embolism (blood clot in blood vessels supplying the lung)

Safety update

  • Review of Adakveo (crizanlizumab) - CHMP Opinion
    Prevention of painful crises in patients with sickle cell disease

May 2023

New information on authorized medicines

  • Adempas (riociguat) – New indication
    Treatment of high blood pressure in lungs in children

Safety update

  • Review of Adakveo (crizanlizumab) review started
    Treatment of painful crises in patients with sickle cell disease

April 2023

Positive CHMP opinions on new medicines

  • Epysqli (eculizumab) – Biosimilar
    Treatment of paroxysmal nocturnal heamoglobinuria

New information on authorized medicines

  • Ultomiris (ravulizumab) – New indication and new pharmaceutical form
    Treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)

Withdrawal of applications for new medicines

  • Feraheme (ferumoxytol)
    Intended for treatment of iron deficiency anaemia

Safety update

Direct Healthcare Professional Communication (DHPC)

  • Janus kinase inhibitors (JAKi) (abrocitinib, filgotinib, baricitinib, upadacitinib, tofacitinib) Updated recommendations to minimize risk of cancer, heart problems and blood clots

March 2023

Positive CHMP opinions on new medicines

  • Bekemv (eculizumab) – Biosimilar medicine
    Treatment of paroxysmal nocturnal haemoglobinuria
  • Tibsovo (ivosidenib) - Orphan medicine
    Treatment of myeloid leukaemia
  • Tidhesco (ivosidenib) - Orphan  medicine
    Treatment of myeloid leukaemia
  • Vafseo (vadadustat) Treatment of anaemia associated with chronic kidney disease

New medicines authorized

  • Plerixafor Accord (plerixafor) - generic of Mozobil
    Medicine used in cancer patients to obtain cells from the bone marrow for use in transplantation

Direct Healthcare Professional Communication (DHPC)

  • Adakveo (crizanlizumab)
    Treatment of anaemia
  • Neofordex (dexamethasone)
    Treatment of multiple myeloma

February 2023

New information on authorized medicines

  • Reblozyl (luspatercept) – Extension of indication – Orphan medicine
    New indication: Treatment of anemia in patients with beta-thalassaemia

Safety update

  • Review of Adakveo (crizanlizumab) - Review started (Scope of safety referral)
  • Prevention of painful crises in patients with sickle cell disease

January 2023

Positive CHMP opinions on new medicines

  • Hemgenix (etranacogene dezaparvovec) – Orphan Medicine, conditional approval
    Treatment of severe and moderately severe hemophilia B

New medicines authorized

  • Pyrukynd (mitapivat) – Orphan medicine
    Treatment of adults with pyruvate kinase deficiency

New information on authorized medicines

  • Hemlibra (emicizumab) – Extension of indication
    New indication: routine prophylaxis of bleeding episodes in patients with hemophilia A without factor VIII inhibitors who have moderate disease with severe bleeding phenotype

November 2022

Positive CHMP opinions on new medicines

  • Ebvallo (tabelecleucel) – Orphan Medicine, Exceptional circumstances
    Treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
     
  • Plerixafor Accord (plerixafor) – Generic of Mozobil
    Treatment of blood cancer after bone marrow transplantation

New medicines authorized

New information on authorized medicines

  • Brukinsa (zanubrutinib) – Orphan Medicine
    Treatment of chronic lymphocytic leukemia

September 2022

Positive CHMP opinions on new medicines

  • Enjaymo (sutimlimab) – Orphan Medicine
    Treatment of hemolytic anaemia

  • Pyrukynd (mitapivat) – Orphan Medicine
    Treatment of pyruvate kinase deficiency

  • Zynlonta (loncastuximab tesirine) – Orphan Medicine
    Treatment of diffuse large B-cell lymphoma and high-grade B-cell lymphoma 

August 2022

New information on authorized medicines

  • 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) – Orphan medicine, Conditional Approval
    New indication: Treatment of mantle cell lymphoma

Withdrawal of applications for new medicines

July 2022

New information on new medicines

  • Tecvayli (teclistamab) - recommended for conditional marketing authorization
    Treatment of relapsed and refractory multiple myeloma

Positive CHMP opinions on new medicines

  • Pepaxti (melphalan flufenamide) – Orphan Medicine
    Treatment of multiple myeloma

  • Roctavian (valoctocogene roxaparvovec) – Orphan Medicine – Conditional approval
    Treatment of haemophilia
  • Scemblix (asciminib) – Orphan Medicine
    Treatment of Philadelphia chromosome positive chronic myeloid leukaemia

New medicine authorized

  • Lunsumio (mosunetuzumab) – Orphan Medicine – Conditional approval
    Treatment of follicular lymphoma

New information on authorized medicines

  • Imbruvica (ibrutinib) - Extension of indication
    Treatment of chronic lymphocytic leukaemia

June 2022

Positive CHMP opinions on new medicines

  • Cevenfacta (Eptacog beta (activated))
    Treatment of bleeding episodes

New medicines authorized

  • Breyanzi (lisocabtagene maraleucel)
    Treatment of different types of blood cancers

Withdrawal of applications for new medicines

  • HemAryo (eptacog alfa (activated))
    Intended for treating bleeding episodes and for preventing bleeding after surgical procedures in patients with clotting disorders

April 2022

Positive CHMP opinions on new medicines

  • Carvykti (ciltacabtagene autoleucel) – Conditional approval
    Treatment of multiple myeloma

New medicines authorized

New information on authorized 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 authorized

  • 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 authorized 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 authorized

  • 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 authorized

  • Imatinib Koanaa (imatinib) generic of Glivec
    Treatment of blood cancers and gastrointestinal stromal tumors

New information on authorized 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 authorized

  • 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 authorized 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 authorized

  • 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 authorized

Negative CHMP opinions on new medicines

Withdrawal of applications to change the marketing authorization

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 authorized

  • 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 authorized medicines

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

Withdrawal of authorized medicines

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

Other information

Direct Healthcare Professional Communication (DHPC)

February 2021

New medicines authorized

  • 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 authorized 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 authorized 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 authorized

  • 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 authorized 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 authorized

  • Arsenic trioxide medac (arsenic trioxide) - Generic
    Treatment of acute promyelocytic leukaemia (blood cancer)

New information on authorized 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 authorized

  • 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 authorized

  • 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 authorized 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)