Australia’s Therapeutic Goods Administration has approved Rozlytrek (entrectinib) for treating patients suffering from ROS1 positive non-small cell lung cancer.
Rozlytrek acts by inhibiting tropomyosin receptor tyrosine kinase, receptor tyrosine kinase c-ROS oncogene 1 (ROS1; encoded by the gene ROS1), and anaplastic lymphoma kinase enzymes. The drug also inhibits Janus kinase 2 and tyrosine kinase non-receptor 2.
The drug is approved under the black triangle scheme.
The drug was earlier approved in the United States, and Japan.
The manufacturer has conducted Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/II STARTRK-NG study. In ROS1-positive metastatic NSCLC, the tumors shrank in 78% of people, and the duration of response ranged from 1.8 to 38.8+ months.
About ROS1-positive NSCLC
ROS, a tyrosine kinase, is involved in controlling the growth and proliferation of cells. ROS1 gene fusion results in growth and proliferation, which accounts for 1-2% of non-small-cell lung cancer.