Lorlatinib (Lorbrena) 100mg Tablets | US FDA-Approved ALK Inhibitor for NSCLC | GLT

Generic Information: Lorbrena (Lorlatinib)

Lorbrena (lorlatinib) is a third-generation, brain-penetrant anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinase inhibitor developed by Pfizer. It is engineered to cross the blood-brain barrier and to inhibit both wild-type ALK and a broad range of ALK resistance mutations — including the difficult-to-treat G1202R mutation — making it a cornerstone of treatment for ALK-positive non-small cell lung cancer (NSCLC), including patients with brain metastases. Lorbrena was first approved by the U.S. Food and Drug Administration (FDA) in November 2018 and is now approved in major markets worldwide.

What Is Lorbrena (Lorlatinib) Used For?

Lorbrena (lorlatinib) is indicated for the treatment of adult patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), as detected by an approved test. It is used both as first-line therapy and after disease progression on prior ALK inhibitors (crizotinib or second-generation agents such as alectinib, ceritinib or brigatinib). Its superior central nervous system (CNS) penetration makes it particularly valuable for patients with brain metastases or those at high risk of CNS progression.

In the pivotal phase III CROWN trial, first-line lorlatinib achieved a median progression-free survival beyond three years (3-year PFS rate of 63.5%), reducing the risk of disease progression or death by 73% versus crizotinib. Its intracranial efficacy is exceptional: intracranial objective response rate of 83.3% and intracranial complete response rate of 72.2% in patients with measurable brain metastases.

How Does Lorbrena (Lorlatinib) Work?

Lorlatinib is a macrocyclic, ATP-competitive kinase inhibitor that selectively targets ALK and ROS1. Because it was specifically designed for high CNS penetration, it reaches therapeutic concentrations in the brain and remains active against ALK resistance mutations — including G1202R — that commonly emerge after treatment with earlier-generation ALK inhibitors. By blocking ALK/ROS1 signalling, it suppresses tumour cell proliferation and survival, delivering durable systemic and intracranial disease control.

Indications

• ALK-positive metastatic non-small cell lung cancer (NSCLC) — first-line and post-progression treatment
• Effective against ALK resistance mutations including G1202R
• Active in patients with brain metastases and those at risk of CNS progression

Dosage & Administration

The recommended dose of Lorbrena (lorlatinib) is 100 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity. Tablets should be swallowed whole and must not be chewed, crushed or split. The 25 mg strength is used for dose modification. Dose adjustments are guided by tolerability and may be required in hepatic or renal impairment or with certain concomitant medications. Treatment must be initiated and supervised by an experienced oncologist.

Side Effects

The most common adverse reactions (incidence ≥20%) include edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhoea, mood effects, hypercholesterolemia, hypertriglyceridemia and cough. Patients should be monitored for hyperlipidemia, hypertension, hyperglycemia, central nervous system effects (including mood and cognitive changes), atrioventricular block and interstitial lung disease/pneumonitis. Concomitant use of strong CYP3A inducers is contraindicated. Lorlatinib can cause fetal harm; women of reproductive potential should use effective non-hormonal contraception.

Storage

Store Lorbrena tablets at controlled room temperature in the original packaging, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the box. Ambient (non-cold-chain) shipping is suitable for oral tablets.

Why Choose the GLT?

• Third-generation, brain-penetrant ALK/ROS1 inhibitor — designed by Pfizer for high CNS penetration and activity against resistance mutations including G1202R.
• Longest progression-free survival among ALK inhibitors — CROWN trial median PFS beyond 3 years, 3-year PFS rate 63.5%.
• Exceptional intracranial efficacy — intracranial ORR 83.3% and intracranial CR 72.2% in patients with brain metastases.
• Broadly recommended — preferred first-line ALK-positive NSCLC therapy in NCCN and CSCO guidelines, and the only agent recommended for G1202R-mutant disease.
• Reliable supply by GLT — GIVE LIFE TIME LIMITED ships authentic, batch-traceable Lorbrena with full documentation (CoA and batch records) worldwide.

How to Order Lorbrena (Lorlatinib) from GLT?

1. Contact us via WhatsApp +86 15234153837 or email [email protected] with the product name, specification and quantity.
2. Receive a formal quotation, payment instructions and estimated delivery time.
3. Complete payment via our secure payment channel (Hao Yi Lian / 好易联).
4. Goods are dispatched with batch documentation; tracking provided until delivery.

We serve both licensed institutions (hospital procurement, pharmacies, importers) and individual patients. A valid prescription may be requested before dispatch.

FAQ

1. What strengths of Lorbrena (lorlatinib) are available?

Lorbrena is available as 25 mg and 100 mg film-coated tablets. The recommended dose is 100 mg once daily; the 25 mg strength is used for dose reduction.

2. Is Lorbrena effective against brain metastases?

Yes. Lorlatinib was specifically designed for high CNS penetration and shows strong intracranial activity, including an intracranial complete response rate of 72.2% in the CROWN trial.

3. Does Lorbrena work after other ALK inhibitors fail?

Yes. Lorlatinib retains activity against ALK resistance mutations including G1202R, and is recommended for patients whose disease has progressed on crizotinib or second-generation ALK inhibitors.

4. How is Lorbrena shipped internationally?

As an oral tablet, Lorbrena ships via ambient temperature-controlled courier with full batch documentation (CoA, batch traceability). Typical delivery is 7–14 days depending on destination.

5. Can I order Lorbrena for personal use?

GLT serves both institutions and individual patients. Individual buyers should hold a valid prescription from a licensed physician and use this medicine under oncologist supervision.