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Galinpepimut-S granted orphan drug designation by the EMA
On 13 September 2018, the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) announced that it was to grant Galinpepimut-S (GPS) orphan drug designation, for the treatment of patients with multiple myeloma (MM). This follows fast track designation and orphan drug designation granted by the US Food and Drug Administration (FDA) in July.
GPS targets the Wilms Tumor 1 (WT1) protein present in a number of tumor types and is manufactured by SELLAS Life Sciences (SLS). The product acts as a therapeutic vaccine which stimulates immune activation, and is thought will be beneficial when administered alongside backbone therapies.
This decision is based on data from a phase II trial, in which patients (pts) with high-risk MM were immunized following autologous stem cell transplant (ASCT). Pts administered the vaccine had a median progression-free survival advantage of 11 months, compared to a similar cohort of pts, and the median overall survival (OS) has not yet been reached.
The data was presented at the 44th Annual Meeting of the European Society for Blood and Marrow Transplantation earlier this year – see previous MM Hub article. Phase III trials are now likely to follow to further examine efficacy in MM pts, as well as a number of other indications.
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