FDA approved Rozlytrek (entrectinib) for ROS1-Positive NSCLC and NTRK Fusion-Positive Solid TumorsFDA approved Rozlytrek for Two Types of Advanced Cancer

Rozlytrek is a kinase inhibitor. The exact mechanism of action is not 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 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, and 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. Adult dosage for ROS1-positive NSCLC: 600 mg orally once daily. Adult dosage for NTRK gene fusion-positive solid tumors: 600 mg orally once daily. Pediatric dosage for NTRK gene fusion-positive solid tumors: for patients >6 months, recommended daily dosage based on body surface area (BSA): ≤0.50 m2: 300 mg/m2; 0.51 to 0.80 m2: 200 mg; 0.81 to 1.10 m2: 300 mg; 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 decrease, serum uric acid elevation, and QT interval prolongation. Refer to the full prescribing information for detailed warnings and precautions.

Rozlytrek provides a targeted treatment option for patients with ROS1-positive metastatic NSCLC and for patients with NTRK gene fusion-positive solid tumors. The NTRK indication is approved under accelerated approval based on tumor response rate and durability of response, and continued approval may be contingent upon verification of clinical benefit in confirmatory trials. Patient selection requires detection of ROS1 rearrangement(s) or NTRK gene fusion using an FDA-approved test.