Huge variations between countries in time for reimbursement decisions on new cancer drugs

European Society for Medical Oncology (ESMO), Munich (Germany) – Some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions to reimburse new cancer drugs following their approval by the European Medicines Agency (EMA). The average decision time is longer than one year in some countries, according to a study presented at ESMO 2018 Congress.

Daratumumab receive European license for use in newly diagnosed myeloma

Daratumumab (Darzalex®), an immunotherapy drug for the treatment of myeloma, has been granted marketing authorisation (e.g. a licence) by the European Commission. It is specifically licensed for use in combination with bortezomib (Velcade®), melphalan and prednisolone (D-VMP) in newly diagnosed myeloma patients who are ineligible for high-dose therapy and autologous stem cell transplantation.

Plitidepsin receives second negative recommendation across Europe

Plitidepsin (Aplidin®), a new medicine for the treatment of relapsed and refractory myeloma, has today received a second negative recommendation from the Committee for Medicinal Products for Human Use (CHMP). This decision means that plitidepsin is very unlikely to made available to patients across Europe. This upholds a previous negative recommendation from the CHMP, which was reviewed following an appeal by the pharmaceutical company Pharma Mar.