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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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