All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.

The Multiple Myeloma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your Multiple Myeloma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The Multiple Myeloma 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 Multiple Myeloma Hub cannot guarantee the accuracy of translated content. The Multiple Myeloma Hub 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.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2018-07-25T13:06:10.000Z

Fast Track designation granted for galinpepimut-S

Jul 25, 2018
Share:

Bookmark this article

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.  

  1. https://www.nasdaq.com/press-release/sellas-receives-fast-track-designation-from-fda-for-galinpepimuts-for-the-treatment-of-patients-20180720-00375
  2. https://www.raredr.com/news/multiple-myeloma-treatment-galinpepimuts-receives-fda-fast-track-designation
More about...

Newsletter

Subscribe to get the best content related to multiple myeloma delivered to your inbox