Selected EMA news, 2022

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

• Thalidomide Lipomed (thalidomide) – Biosimilar
  Treatment of multiple myeloma

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

• Parsaclisib Incyte Biosciences Distribution B.V. (parsaclisib)
  Intended for the treatment of marginal zone lymphoma

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

• Zolsketil pegylated liposomal (doxorubicin)
  Treatment of breast and ovarian cancers, multiple myeloma and AIDS-related Kaposi’s sarcoma

New medicines authorized

• 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 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