25 June 2018 - Stemline Therapeutics announced today that it has completed submission of a rolling biologics license application to the U.S. FDA for Elzonris (tagraxofusp; SL-401), a potential treatment for patients with blastic plasmacytoid dendritic cell neoplasm, a CD123+ malignancy of unmet medical need for which the agent was awarded breakthrough therapy designation.

Elzonris (tagraxofusp; SL-401) is a novel targeted investigational therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. Elzonris has successfully completed a pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm, an indication for which it was granted breakthrough therapy designation. 

A rolling biologics license application submission has been completed. Elzonris is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukaemia, myelofibrosis, acute myeloid leukaemia, and myeloma.

Read Stemline Therapeutics press release