Kadmon shares jump on FDA approval of Rezurock for chronic GvHD

Shares in Kadmon Pharmaceuticals were up more than 20% on Friday after the FDA approved its oral kinase inhibitor Rezurock (belumosudil) for chronic graft-versus-host disease (GvHD) in adult and paediatric patients 12 years and older who have failed at least two prior lines of systemic therapy. The company noted the decision makes Rezurock the first FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes.

The filing was granted priority review last year, with the FDA originally expected to render its decision this past May 30. However, the assessment was extended by three months to allow the agency more time to review additional information submitted at its request and that it considered to be a "major amendment" to the application.

The approval was based on results from the pivotal Phase II ROCKstar trial of 132 adults and adolescents with chronic GvHD who have received two to five prior lines of systemic therapy. Participants were randomised to receive Rezurock once or twice daily, and findings were presented late last year at the American Society of Hematology (ASH) annual meeting.

Among the 65 patients given Rezurock 200 mg once daily, the overall response rate was 75% through Cycle 7 Day 1 of treatment, with 6% achieving a complete response and 69% having a partial response. The median time to first response was 1.8 months, while median duration of response, calculated from first response to progression, death or new systemic therapies for chronic GvHD, was 1.9 months. Moreover, Kadmon noted that 62% of responders did not require new systemic therapy for at least a year following response.

Launch due late next month

CEO Harlan Waksal said Rezurock is a "new treatment that uniquely addresses the underlying inflammatory and fibrotic pathophysiology of chronic GvHD," adding that Kadmon has "built a haematology/oncology-experienced commercial team and we look forward to [the drug's] rapid adoption." The company expects to launch the treatment in the US by late August.

The filing was reviewed under the FDA's Real-Time Oncology Review (RTOR) and Project Orbis pilot programmes. The therapy, also known as KD025, was previously granted an orphan drug designation by the FDA for the treatment of chronic GvHD.

July 18th, 2021

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