The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax for the investigational treatment of multiple myeloma.
14 European organisations, including MPE, call for meaningful involvement in European cooperation on HTA
Myeloma Patients Europe has participating along with 13 European Patient organisations in the statement calling on European institutions to adopt appropriate measures to incorporate meaningful involvement of patients in EU cooperation on health technology assessment (HTA).
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 (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.
Daratumumab (Darzalex®), an immunotherapy drug for the treatment of myeloma, has received a positive recommendation by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Prothena Corporation, a pharmaceutical company in neuroscience and orphan disease, has announced that it is discontinuing development of NEOD001, a drug being researched in clinical trials for the treatment of AL amyloidosis patients. The decision was taken because NEOD001 did not do as well as expected in its clinical development programme.
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.
The European Commission has issued a legislative proposal to the European Council and European Parliament on further integration of health technology assessment (HTA) in the EU.
Plitidepsin (Aplidin®), a new medicine for the treatment of relapsed and/or refractory myeloma, has today received a negative recommendation from the Committee for Medicinal Products for Human Use (CHMP). The decision means that, as it stands, plitidepsin is unlikely to be made available for myeloma patients across Europe.