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 Know AML.

The AML 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

Join our

Treating classical Hodgkin lymphoma: Spotlight on targeted therapies

with Gilles Salles, Paul Bröckelmann, and Ann S. LaCasce

Saturday, November 2, 2024
8:50-9:50 CET

Register now

This independent educational activity is sponsored by Takeda. All content is developed independently by the faculty. Funders are allowed no direct influence on the content of this activity.

  TRANSLATE

The AML 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 AML Hub cannot guarantee the accuracy of translated content. The AML 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.

The AML Hub is an independent medical education platform, sponsored by Daiichi Sankyo, Jazz Pharmaceuticals, Kura Oncology, Roche and Syndax and has been supported through a grant from Bristol Myers Squibb. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

2023-11-27T18:28:07.000Z

Mocravimod granted Orphan Drug Designation by the FDA

Nov 27, 2023
Share:
Learning objective: After reading this article, learners will be able to cite a new clinical development in AML

On November 27, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to mocravimod (also known as KRP203), a novel synthetic sphingosine-1-phosphate receptor modulator, to improve outcome after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematologic malignancies.1

Mocravimod was previously granted Orphan Drug Designation by the U.S. FDA and the European Medicines Agency (EMA) for the treatment of patients with acute myeloid leukemia undergoing allo-HSCT.2 The safety and efficacy of mocravimod, both as an adjunctive and maintenance therapy, for patients with acute myeloid leukemia receiving allo-HSCT is currently being investigated in the phase III MO-TRANS trial (NCT05429632), which will enroll around 250 adult patients.1

  1. Priothera–US FDA grants Orphan Drug Designation to mocravimod to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematologic malignancies. https://priothera.com/priothera-us-fda-grants-orphan-drug-designation-to-mocravimod-to-improve-the-outcome-of-allogeneic-hematopoietic-stem-cell-transplantation-allo-hsct-in-patients-with-hematologic-malignanci/. Published Nov 27, 2023. Accessed Nov 27, 2023.
  2. Priothera–FDA and EMA Grant Orphan Drug Designation to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). https://priothera.com/priothera-fda-and-ema-grant-orphan-drug-designation-to-mocravimod-for-the-treatment-of-acute-myeloid-leukemia-aml-in-patients-undergoing-allogeneic-hematopoietic-stem-cell-transplantation/. Published Mar 3, 2022. Accessed Nov 27, 2023.

Your opinion matters

HCPs, what is your preferred format for educational content on the AML Hub?
11 votes - 11 days left ...

Newsletter

Subscribe to get the best content related to AML delivered to your inbox