Posted by Michael Wonder on 04 May 2026
New first in class therapy for chronic graft versus host disease approved in Australia
3 May 2026 - Specialised Therapeutics is pleased to announce that Niktimvo (axatilimab) has been approved for use in Australia by the TGA for the treatment of chronic graft versus host disease after failure of at least two prior lines of systemic therapy in adult and paediatric patients 6 years and older weighing at least 40 kg.
Niktimvo was assessed through the TGA's priority review pathway and is the first approved anti-colony stimulating factor-1 receptor antibody for chronic graft versus host disease.
