Selected EMA news, March 2025

New medicines recommended for approval

  • Lynozyfic (linvoseltamab)
    Treatment of refractory multiple myeloma (a cancer of the bone marrow)

New information on approved medicines

  • Calquence (acalabrutinib) – new indication
    Treatment of blood cancer
  • Columvi (glofitamab) – new indication
    Treatment of blood cancer
  • Darzalex (daratumumab) – change of indication
    Treatment of multiple myeloma (a cancer of the bone marrow) and light chain amyloidosis (a blood disease in which deposits of abnormal proteins, called amyloids, accumulate and cause damage in tissues and organs)
  • Fabhalta (iptacopan) – new indication
    Treatment of complement 3 glomerulopathy (a kidney disease) and paroxysmal nocturnal haemoglobinuria, a disease in which there is an excessive breakdown of blood cells
  • Jaypirca (pirtobrutinib) – new indication
    Treatment of blood cancer

Other EMA news

  • In a joint statement, EMA and the Heads of Medicines Agencies (HMA) warn the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.
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