Kadmon’s Rezurock (belumosudil) Receives the US FDA’s Approval for the Treatment of Chronic Graft Versus Host Disease

July 20, 2021 Auto Bot approval, FDA, Kadmon, regulatory 0

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

Click here to read full press release/ article | Ref:  kadmon | Image: LinkedIn

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