The Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for Pomalidomide (Pomalidomide Celgene®) in the treatment of multiple myeloma for relapsed and refractory myeloma patients. The next step is for the European Commission to adopt the final licensing decision within three months. There is no doubt that this is a crucial step for patients within the EU…
The MC held in Madrid on 13 April 2013 was a great success. We had the honour to have with us some highly qualified speakers who specialise in personalised medicine. Also the ethical implications of personalised medicine were discussed in depth.
Madrid, Saturday 13 April 2013 (9:00am – 4:30pm) After the success of MPe’s I Masterclass that took place in Edinburgh last year, the second one will follow this spring focusing on myeloma genetics and the role of bio banks. The issue will be presented and discussed from a medical point of view, but also from the patient perspective, particularly concerning the ethical issues involved in these kind of treatments.
On the 12 March Aeterna Zentaris announced the discontinuation of their Phase III myeloma study of perifosine subsequent to a recommendation by the Data Safety Monitoring Board (DSMB). According to the DSMB, the pre-planned interim analysis of efficacy and safety indicates that the study may not reach the significant difference in progression free survival, the primary endpoint.