FDA Orphan Status for Myeloma T Cell Therapy
FDA Orphan Status for Myeloma T Cell Therapy image
FDA Orphan Status for Myeloma T Cell Therapy
Posted May 10, 2018

The U.S. Food & Drug Adminstration (FDA) granted orphan status to a targeted immunotherapy drug for myeloma called galinpepimut (GPS) on May 9, 2018. 

GPS is a vaccine that targets the WT1 antigen which, according to manufacturer SELLAS Life Sciences Group, “is one of the widely expressed cancer antigens” found a variety of cancer types, including myeloma.  According to dictionary.com, antigens “stimulate the production of antibodies and combine specifically with them.”

The vaccine manipulates a person’s own immune system and other drugs to produce more CD4 and CD8, molecules on cells that identify and stimulate activity on T cells which then attack and kill myeloma cells.

SELLAS, a spinoff business from Memorial Sloan Kettering Cancer Center, has “reported median progression-fee survival (PFS) of 23.6 months in the high-risk MM setting” as compared 12 months with other treatments.

SELLAS is developing GPS vaccines for other cancers including solid and liquid tumors.

The author Greg Brozeit

about the author
Greg Brozeit

Greg Brozeit has been engaged in myeloma patient advocacy since 1998. He began working with the Myeloma Crowd in 2015. Prior to that, he consulted with Dr. Bart Barlogie at the University of Arkansas after working with the International Myeloma Foundation for 15 years, where he inaugurated the public policy advocacy program, patient support group outreach and IMF Europe, organizing more than 100 physician and patient education programs. He earned his BA in political science from Loyola University in New Orleans and lives in northeast Ohio.

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