BRIEF—Eisai gets approval for Remitoro in Japan

Eisai has won Japanese approval for Remitoro (denileukin diftitox) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL) and relapsed or refractory cutaneous T-cell lymphoma (CTCL).

The decision was based on results from the Phase II Study 205, which achieved its primary endpoint with an objective response rate (ORR) of 36.1%.

Developed by Ligand Pharmaceuticals, Eisai retains exclusive development and marketing rights for the agent in Japan and Asia.

Marketed elsewhere as Ontak, the product is an engineered protein combining interleukin-2 and diphtheria toxin, which binds to IL-2 receptors.