Fast Track designation granted for galinpepimut-S

On 20 July 20018 SELLAS Life Sciences (SES) announced that the US Food and Drug Administration (FDA) had granted Fast Track designation to Galinpepimut-S (GPS), for the treatment of multiple myeloma (MM). GPS is a therapeutic cancer vaccine that targets cancer cells expressing the Wilms Tumor 1 (WT1) protein. Cells from myeloma patients have been shown to fall into this category, with promising benefits observed in clinical trials.

This decision was based on data from a phase II trial presented at the 44th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) earlier this year. GPS was also granted orphan drug designation by the FDA in May 2018 – see previous article.

This designation accelerates the FDA process of approval and is reserved for diseases that lack treatment options. The vaccine as it stands is likely to see a place in the market “for select high-risk MM patients in the post-autotransplant maintenance setting after standard first-line treatment", according to SELLAS’ President and Chief Executive Officer, Angelos Stergiou.