Rozlytrek is a tumour-agnostic medicine that represents a new approach to treating cancer. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.
Rozlytrek is approved as a once-daily oral medicine for the treatment of NTRK fusion-positive solid tumours and ROS1-positive non-small cell lung cancer in several countries including Australia, Canada, Israel, Japan, New Zealand, South Korea, Taiwan and the US, with further regulatory reviews ongoing around the world.
Rozlytrek was granted Breakthrough Therapy designation by the US Food and Drug Administration, Sakigake designation for accelerated review by Japan’s Ministry of Health, Labour and Welfare, and Priority Medicines designation by the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for Rozlytrek in May 2020, and a final decision regarding the approval of Rozlytrek by the European Commission is expected in the coming months.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals and patients are asked to report any suspected adverse reactions. See our information for details on how to report.