Entrectinib (Rozlytrek) is a novel kinase inhibitor that has demonstrated significant efficacy in oncology treatment through a precisely targeted therapeutic mechanism.

What Are the Indications of Entrectinib (Rozlytrek)?

ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

This product is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), confirmed by an FDA-approved detection method.

The establishment of this indication is based on the key role of ROS1 gene rearrangement in tumorigenesis; tumor growth control is achieved by inhibiting the activity of relevant kinases.

NTRK Gene Fusion-Positive Solid Tumors

This product is indicated for the treatment of adult and pediatric patients aged over 1 month with solid tumors.

The following conditions must be met: the presence of neurotrophic tyrosine receptor kinase (NTRK) gene fusion confirmed by an FDA-approved detection method, and no known acquired drug resistance mutations.

The tumor is in a metastatic state, or surgical resection may lead to severe complications.

Disease progression occurs after previous treatment, or there is no satisfactory alternative treatment plan.

Specifications and Properties of Entrectinib (Rozlytrek)

Capsule Dosage Form Specifications

100 mg capsules: Size 2 yellow opaque capsules, with blue "ENT100" markings on both the cap and the body.

200 mg capsules: Size 0 orange opaque capsules, with blue "ENT200" markings on both the cap and the body.

Oral Granule Dosage Form

50 mg/package: Brown-orange or gray-orange round film-coated granules.

Formulation Composition

The active ingredient is entrectinib. The excipient system for capsules includes tartaric acid, anhydrous lactose, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.

Excipients for granules include tartaric acid and microcrystalline cellulose; the film coating contains materials such as polyvinyl alcohol and titanium dioxide.

Storage Conditions of Entrectinib (Rozlytrek)

Capsule Dosage Form

Store at standard room temperature between 20°C and 25°C (68°F and 77°F).

Short-term storage between 15°C and 30°C (59°F and 86°F) is allowed.

Oral Granule Dosage Form

Store at a temperature between 20°C and 25°C (68°F and 77°F); short-term storage between 15°C and 30°C (59°F and 86°F) is allowed.

Special Storage Requirements

All dosage forms must be stored in their original packaging, sealed to prevent deliquescence.

When capsules are reconstituted into an oral suspension, if stored at room temperature below 30°C (86°F), the suspension must be used within 2 hours.

Oral granules must be stored in their original container to prevent moisture absorption.