Kadmon Plans NDA for Graft-Versus-Host Disease

Kadmon Holdings says it has received FDA meeting minutes on a planned NDA submission for KD025 for treating patients with chronic graft-versus-host disease (cGVHD). Based on the FDA feedback, the company believes its proposed data package will be sufficient to support the NDA, which will include data from the primary analysis of the ROCKstar (KD025-213) study. Kadmon says FDA plans to submit one-year follow-up data from the study within 60 days of the initial submission (fourth quarter).

Kadmon previously reported that the study met the primary endpoint of overall response rate based on an interim analysis. KD025 showed statistically significant and clinically meaningful overall response rates of 64% with KD025 200 mg once daily and 67% with KD025 200 mg twice daily, it says.

In 10/2018, KD025 was granted a breakthrough therapy designation by FDA for treating patients with cGVHD who have received at least two prior lines of systemic therapy.