Rozlytrek Approved for Solid Tumors with NTRK Gene Fusion and for Metastatic ROS1-Positive NSCLC

On August 15, 2019, the FDA granted accelerated approval to entrectinib (Rozlytrek; Genentech) for the treatment of patients aged ≥12 years with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed after treatment or have no satisfactory standard therapy.

On the same day, the FDA also approved this drug for the treatment of adult patients with metastatic ROS1-positive non–small-cell lung cancer (NSCLC).

The approval of entrectinib for solid tumors was based on data from 54 patients with NTRK gene fusion–positive tumors, including breast, thyroid, and colorectal cancer, who received the drug at various doses and schedules in several single-arm clinical trials. The overall response rate (ORR) was 57%, with complete disappearance of tumors reported in 7.4% of patients.

The approval of entrectinib for metastatic lung cancer was based on results from 51 patients with ROS1-positive NSCLC who received the drug in various doses and schedules in the same single-arm clinical trials. The ORR was 78%, with complete disappearance of tumors reported in 5.9% of patients.

The most common (≥20%) adverse reactions in patients who received entrectinib were fatigue, constipation, altered sense of taste, edema, dizziness, diarrhea, nausea, nervous system disorders, shortness of breath, muscle pain, cognitive impairment, increased weight, cough, vomiting, fever, joint pain, and vision disorders.

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