Posted by Michael Wonder on 01 Oct 2020
Kadmon announces submission of new drug application to the U.S. FDA for belumosudil in patients with chronic graft versus host disease
30 September 2020 - Application being reviewed under FDA's Real-Time Oncology Review pilot program.
Kadmon Holdings today announced the submission of a new drug application to the U.S. FDA for belumosudil (KD025), the Company's Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, for the treatment of patients with chronic graft-versus-host disease (cGVHD).
The submission is supported by positive data from ROCKstar (KD025-213), the Company's pivotal clinical trial evaluating belumosudil in 132 patients with cGVHD who have received two or more prior lines of systemic therapy.
