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FDA grants Orphan Drug Designation to STRO-001 for the treatment of multiple myeloma

Oct 17, 2018

On 12 October 2018, the  US Food and Drug Administration (FDA) granted Orphan Drug Designation to STRO-001, a first-in-class antibody-drug conjugate (ADC), for the treatment of patients with multiple myeloma (MM). 1

CD74, a transmembrane glycoprotein involved in the formation and transport of MHC proteins, has been reported to have a high expression in up to 90% of B-cell malignancies, including MM, with minimal expression in normal tissues.  STRO-001 is a novel ADC targeting CD74 glycoprotein. Preclinical data have shown that STRO-001 demonstrates a potent cytotoxicity in MM cell lines and reduces tumor burden in MM xenograft models, including significant prolongation of survival in the MM.1S model. 2

A first-in-human phase I, open-label, multicenter, dose-escalation study  ( NCT03424603) evaluating the safety, tolerability, and preliminary anti-tumor activity of STRO-001 in adult subjects with B-cell malignancies including MM and non-Hodgkin lymphoma who are refractory to, or intolerant of all established therapy known to provide clinical benefit for their conditions is currently ongoing.

  1. PR Newswire: Sutro's STRO-001 Receives U.S. FDA Orphan Drug Designation for Treatment of Multiple Myeloma. 2018 Oct 12. https://www.prnewswire.com/news-releases/sutros-stro-001-receives-us-fda-orphan-drug-designation-for-treatment-of-multiple-myeloma-300730084.html[Accessed 2018 Oct 16].
  2. Embry M. et al. Targeting CD74 in multiple myeloma with a novel antibody-drug conjugate(ADC), STRO-001. Abstract #P328. 2017 Congress of the European Hematology Association.