The mm Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mm Hub cannot guarantee the accuracy of translated content. The mm and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Multiple Myeloma Hub is an independent medical education platform, sponsored by Bristol Myers Squibb, GSK, Johnson & Johnson, Pfizer, Roche and Sanofi. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View mm content recommended for you
Galinpepimut-S granted FDA orphan drug designation
On 9 May 2018, SELLAS Life Sciences (SLS) announced that its therapeutic vaccine, Galinpepimut-S (GPS), has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). GPS targets the Wilm’s Tumor-1 (WT-1) protein, a known tumor antigen which, along with an adjuvant, stimulates the immune system to fight back. It has been suggested that this could prove highly beneficial if given in combination with other immunomodulatory drugs.
The vaccine is currently licensed from the Memorial Sloan Kettering Cancer Center, where the research has been carried out, including a phase II trial in which 19 patients with high-risk disease were immunized with GPS following autologous stem cell transplant (ASCT). A median progression-free survival (PFS) of 23.6 months was reported, an 11-month increase compared to data from a comparative trial with a similar sub-group of high-risk patients. An 88% overall survival (OS) of 18 months was also recorded.
A study to assess the clinical benefit of the vaccine in high-risk patients was conducted by Guenther Koehne and presented at the 44th Annual Meeting of the European Society for Blood and Marrow Transplantation earlier this year – see previous MM Hub article.
References