Drugs

FDA Extends Review Date for Kadmon’s Belumosudil

FDA has extended the PDUFA review date for Kadmon Holding’s belumosudil for treating chronic graft-versus-host disease (cGVHD) from 3/9 to 8/30. The agency told the company the extension allowed time to review additional information submitted by Kadmon in response to a recent agency information request.

Belumosudil is described as a selective oral inhibitor of Rho-associated coiled-coil kinase 2, a signaling pathway that modulates inflammatory response and pro-fibrotic processes. FDA accepted the firm’s NDA 11/2020 and granted it priority review. FDA has granted belumosudil breakthrough therapy designation for treating patients with cGVHD after failure of two or more lines of systemic therapy as well as orphan drug designation for treating cGVHD.

The NDA is being reviewed under the agency’s Real-Time Oncology Review and Project Orbis pilot programs.

FDA Extends Review Date for Kadmon’s Belumosudil

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