Shots:

• The approval is based on KD025-213 study evaluating Rezurock (200 mg- qd) aged >12 yrs. in 65 patients with cGVHD who had received 2 to 5 prior lines of systemic therapy. The anticipated PFUFA date is Aug 30- 2021
• Results: ORR (75%) through Cycle 7- day 1 treatment with CR (6%) & PR (69%); median time to 1st response (1.8mos.)- 62% of responders did not require new systemic therapy for at least 12mos. following response- m-DoR (1.9mos.)- a median time from cGVHD diagnosis was 25.3 mos.
• Rezurock (belumosudil) is the 1st approved therapy targeting ROCK2 and expected to be available in the US in Aug’21. The FDA has granted BTD & PR for Rezurock & reviewed the NDA under RTOR pilot program

Ref:  kadmon | Image: LinkedIn