FDA Grants Priority Review for Entrectinib in ROS1-Positive NSCLC
Posted: Monday, February 25, 2019
The U.S. Food and Drug Administration (FDA) recently accepted new drug applications and granted Priority Review for entrectinib in the treatment of patients with metastatic, ROS1-positive non–small cell lung cancer (NSCLC). Entrectinib is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation of certain types of cancer.
This new drug approval is based on results from the integrated analysis of the phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials, as well as data from the phase I/Ib STARTRK-NG study. The FDA is expected to make a decision on approval by August 18, 2019.
Results from an integrated analysis of data from 53 people with ROS1-activating gene fusions and 54 people with locally advanced or metastatic NTRK fusion–positive solid tumors showed an objective response rate of 57.4% in patients treated with entrectinib with NTRK fusion–positive solid tumors. Entrectinib shrank tumors in 77.4% of people with locally advanced or metastatic ROS1-positive NSCLC.
The safety profile of entrectinib was consistent with that seen in previous analyses. The most commonly reported adverse reactions included fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, pain, anemia, cognitive disorders, weight increase, vomiting, cough, blood creatinine increase, arthralgia, pyrexia, and myalgia.
