FDA approved Rozlytrek (entrectinib) for ROS1-Positive NSCLC and NTRK Fusion-Positive Solid TumorsFDA approved Rozlytrek for Certain Lung and Solid Tumors

Rozlytrek is a kinase inhibitor. The exact mechanism of action is not further described in the label.

Rozlytrek is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. It is also indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The NTRK indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select patients based on the presence of ROS1 rearrangement(s) or NTRK gene fusion. Evaluate left ventricular ejection fraction, serum uric acid levels, QT interval, and electrolytes prior to initiation. Select appropriate dosage form: oral capsules, capsules prepared as an oral suspension, or oral pellets. Use capsules prepared as suspension for enteral tube administration. Do not use pellets for enteral tube administration. Administer once daily, with or without food. For ROS1-positive NSCLC, the adult dose is 600 mg orally once daily. For NTRK gene fusion-positive solid tumors, the adult dose is 600 mg orally once daily. For pediatric patients, the recommended dosage is based on age and body surface area (BSA): for patients >6 months, BSA ≤0.50 m2: 300 mg/m2; BSA 0.51 to 0.80 m2: 200 mg; BSA 0.81 to 1.10 m2: 300 mg; BSA 1.11 to 1.50 m2: 400 mg; BSA ≥1.51 m2: 600 mg once daily. For patients >1 month to ≤6 months, 250 mg/m2 once daily. Modify dosage if coadministration with moderate or strong CYP3A inhibitors cannot be avoided. See preparation and administration instructions.

Trial data not available in label.

The label does not list contraindications. Warnings and precautions include left ventricular ejection fraction, serum uric acid levels, and QT interval and electrolytes. See full prescribing information for details.

Rozlytrek provides a targeted therapy option for patients with ROS1-positive metastatic NSCLC and NTRK gene fusion-positive solid tumors. The NTRK indication is under accelerated approval, and continued approval may depend on confirmatory trials. Selection of patients should be based on FDA-approved tests for ROS1 rearrangements or NTRK gene fusions.