Aussie discovery goes commercial

Specialised Therapeutics (ST) has secured the TGA’s approval for chronic graft-versus-host disease (cGCVHD) treatment Niktimvo, developed off the back of QIMR Berghofer scientists’ research, with the company currently “exploring” listing the drug on the PBS.

Assessed under the TGA’s priority review pathway, the first-in-class colony stimulating factor-1 receptor (CSF-1R) blocking antibody has been approved for the treatment of cGVHD after failure of at least two prior lines of systemic therapy in adult and paediatric patients six years and older weighing at least 40 kg.

Niktimvo falls under ST’s partnership with Incyte, which includes TGA approved Minjuvi and Pemazyre plus PD-1 inhibitor Zynyz, which was accepted for TGA review in June 2025.