The GvHD 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

Submission of biologics license application to FDA for inolimomab for treatment of steroid-refractory acute GvHD in adult patients

Jul 28, 2020

The U.S. Food and Drug administration (FDA) have agreed to start a submission process for a Biologics License Application (BLA) for inolimomab for the treatment of adult patients with Grade 2–4 steroid-refractory acute graft- versus-host disease (aGvHD). 1This move comes following the demonstration of the significant and durable efficacy of inolimomab in a randomized multicenter phase III study ( INO-0107—EUDRACT 2007-005009-24). While this trial did not meet its primary endpoint (overall survival after 1 year), patients treated with inolimomab showed a more favorable outcome after longer term follow-up compared to those who had received antithymocyte globulin. 2

The BLA will be reviewed under the FDA’s Real-Time Oncology Review pilot program, which aims to make the reviewing process more efficient.

Inolimomab is a monoclonal antibody that targets interleukin-2 (IL-2) and is involved in the development and multiplication of certain white blood cells, including T cells responsible for aGvHD. Inolimomab blocks IL-2 from binding to CD25 by specifically linking to and blocking the receptor on the surface of the T cell, preventing their proliferation.

  1. ElsaLyc Biotech. ElsaLys Biotech announces submission of Biologics License Application to FDA for Leukotac® (inolimomab) for the treatment of graft-versus-host disease in adult patients. https://www.elsalysbiotech.com/node/113. Published July 23, 2020. Accessed July 27, 2020.
  2. Socié G, Milpied N, Yakoub-Agha I, et al. Long-term follow-up of a phase 3 clinical trial of inolimomab for the treatment of primary steroid refractory aGVHD.  Blood Adv. 2019;3(2):184-186. DOI: 1182/bloodadvances.2018028282