'We are very pleased to announce the approval of Rozlytrek for the treatment in adults with ROS1 fusion-positive NSCLC. Rozlytrek was launched last year as Chugai's first product to embody advanced personalized healthcare for the treatment of patients with NTRK fusion-positive solid tumors regardless of their age or site of origin,' said Dr.
This approval is based mainly on the results of an open-label, multicenter, global phase II STARTRK-2 study. Efficacy was evaluated in ROS1 fusion-positive NSCLC cohort from the STARTRK-2 study while safety was evaluated in two overseas phase I studies (STARTRK-1 study and ALKA-372-001 study) in addition to STARTRK-2 study.
FoundationOne CDx Cancer Genomic Profile is used as a companion diagnostic to identify people that could potentially benefit from Rozlyterk for the ROS1 fusion-positive, unresectable, advanced or metastatic NSCLC. The MHLW granted the approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of Rozlytrek on
About ROS1 fusion-positive NSCLC
ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes (CD74, etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is thought to promote cancer cell proliferation. ROS1 fusion gene is found in about 1 to 2% of NSCLC, among which it is more expressed in adenocarcinoma.1)
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
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