FDA Grants Breakthrough Therapy Designation for Solid Tumor Treatment

The FDA has granted breakthrough therapy designation to repotrectinib as a treatment for patients with advanced solid tumors with NTRK gene fusion who have progressed after one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, who have no other viable alternatives. 

The release noted that repotrectinib was granted Orphan Drug designation in 2017 and was previously granted a Breakthrough Therapy designation in ROS1-positive metastatic non-small cell lung cancer (NSCLC) patients who have not been treated with an ROS1 tyrosine kinase inhibitor. 

The FDA has also granted repotrectinib Fast-Track designations for ROS1-positive patients who are ROS1 TKI naïve, ROS1-positive advanced NSCLC patients who have been treated with a prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC patients who have been treated with one prior ROS1 TKI without prior platinum-based chemotherapy; and NTRK-positive patients with advanced solid tumors who have progressed after treatment with at least one previous line of chemotherapy and one or two prior TRK TKIs and have no viable alternatives. 

Following the most recent designation, the release said the manufacturer plans to work with the FDA to discuss future steps for the medication early next year.