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FDA Grants Breakthrough Therapy Designation to Repotrectinib for Solid Tumors With NTRK Gene Fusions

By: JNCCN 360 Staff
Posted: Tuesday, October 12, 2021

On October 6, the U.S. Food and Drug Administration (FDA) granted BreakthroughTtherapy designation to repotrectinib for the treatment of patients with solid tumors that have an NTRK gene fusion. These patients must have experienced disease progression after being treated with one to two previous tyrosine kinase inhibitors (TKIs) with or without chemotherapy and must have no other treatment options. Repotrectinib is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non–small cell lung cancer (NSCLC) and other advanced solid tumors.

The Breakthrough Therapy designation is the seventh regulatory designation for repotrectinib. The FDA is expected to decide on repotrectinib’s potential registration for treatment in patients with solid tumors and NTRK gene fusions at a Type B meeting in early 2022.

The FDA’s decision was based on interim data from the phase I/II TRIDENT-1 clinical trial investigating the effectiveness of repotrectinib in patients with ROS1-positive metastatic NSCLC. The study included two cohorts of patients with NTRK gene fusions. Results showed a 91% overall response rate in 11 patients and an 86% overall response rate in patients with ROS1-positive, TKI-naive disease. The median duration of response with repotrectinib was 23.1 months. Additionally, the median progression-free survival was 24.6 months.

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