Rozlytrek (Entrectinib) 200mg Capsules | China NMPA-Approved NTRK/ROS1 Inhibitor | GLT

What is Rozlytrek (Entrectinib) Used For?

Rozlytrek (entrectinib, 罗圣全) is an oral kinase inhibitor developed by Roche that selectively targets NTRK1/2/3 (TRKA/B/C) and ROS1. It is approved by China's NMPA (July 2022) for two indications: (1) adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC); and (2) adult and pediatric patients (12 years and older) with NTRK gene fusion-positive solid tumors. Rozlytrek was China's first approved ROS1/NTRK dual-target inhibitor.

How Does Rozlytrek Work?

Entrectinib inhibits TRKA, TRKB, and TRKC (encoded by NTRK1/2/3) and ROS1 kinases. NTRK fusions and ROS1 rearrangements drive tumor growth across multiple cancer types. A key advantage is its strong blood-brain barrier penetration, which delivers meaningful intracranial activity — a critical benefit for patients with brain metastases, where control rates are substantially higher than earlier-generation ROS1 inhibitors.

Approved Indications

• ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) — adult patients
• NTRK gene fusion-positive solid tumors — adult and pediatric patients (12 years and older)

Clinical Efficacy (China Cohort)

• Objective response rate (ORR): ~75% (China subgroup, consistent with global STARTRK-2 data)
• Median progression-free survival (mPFS): ~16.8 months
• Intracranial (brain metastasis) ORR: ~50% — significantly better than crizotinib
• Works across treatment lines (first-line and later-line)

Dosage & Administration

The recommended adult dosage is 600 mg orally once daily, with or without food. Available strengths: 100 mg and 200 mg capsules. Pediatric dosing (12 years and older) is based on body surface area. Do not crush, chew, or open capsules. Select patients based on ROS1 rearrangement or NTRK gene fusion detected by an approved test (RT-PCR or NGS).

Warnings & Precautions

• Congestive heart failure — assess left ventricular ejection fraction before initiation and monitor
• Central nervous system effects — cognitive impairment, mood disorders, dizziness, sleep disturbances
• Skeletal fractures — increased fracture risk
• Hepatotoxicity — monitor ALT/AST every 2 weeks during the first month, then monthly
• Hyperuricemia and QT interval prolongation — assess at baseline and monitor
• Vision disorders — withhold for new or worsening visual changes

Common Side Effects

Common adverse reactions include fatigue, constipation, dysgeusia (altered taste), dizziness, diarrhea, nausea, and peripheral edema. Report persistent or severe symptoms to your physician.

Storage

Store at room temperature (20°C to 25°C) in the original container, protected from moisture. Keep out of reach of children.

Why Choose GLT for China-Sourced Rozlytrek?

• NMPA-approved, China-sourced original Roche product at competitive China pricing
• Hong Kong-licensed pharmaceutical wholesaler with verifiable business registration
• Full product documentation: COA, MSDS, and regulatory dossiers
• Cold-chain (2-8°C) for biologics & injectables; ambient shipping for capsules
• Serving both institutions (hospitals, pharmacies, distributors) and individual patients
• Global shipping with customs documentation and secure delivery

How to Order

Contact GLT via WhatsApp (+86 15234153837) or email ([email protected]) for pricing, availability, and full documentation including COA, MSDS, and regulatory dossiers. Responses within 24 hours.

Frequently Asked Questions

Q: Is this the China-market Rozlytrek?
A: Yes. This listing is the China (NMPA-approved) Roche original-brand product, 200 mg capsules × 90's, sourced from Roche Pharmaceuticals (China). It is China's first ROS1/NTRK dual-target inhibitor.

Q: What is the difference from the Hong Kong or Korea version?
A: The active ingredient (entrectinib) is identical; versions differ by manufacturer subsidiary and market registration. The China version is NMPA-approved and offers significant cost advantage.