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

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).¹ This 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.