Lorbrexen is identified on this website as a product containing 100 mg of lorlatinib.
Product identity
| Product characteristic | Information |
|---|---|
| Product | Lorbrexen |
| Active ingredient | Lorlatinib |
| Stated strength | 100 mg |
| Dosage form | Film-coated tablet |
| Route | Oral, subject to product documentation |
| Drug class | ALK tyrosine kinase inhibitor |
| Therapeutic category | Antineoplastic |
| U.S. reference brand | LORBRENA |
| European brand | Lorviqua |
| Original developer | Pfizer |
| Lorbrexen manufacturer | Everest Pharmaceuticals Ltd. |
Therapeutic role
Lorlatinib is used in selected patients with ALK-positive advanced or metastatic NSCLC. The precise approved indication depends on the jurisdiction.
Mechanism
Lorlatinib inhibits ALK signaling and was designed to address resistance mutations while maintaining CNS penetration.
Reference product
LORBRENA is the U.S. brand for lorlatinib. Lorviqua is used in Europe. Pfizer developed lorlatinib.
Regulatory information
The specific regulatory status of Lorbrexen is Everest Pharmaceuticals Ltd.
The existence of FDA or EMA approval for lorlatinib does not establish regulatory authorization of the separate Lorbrexen-branded product.
Safety
Important risks associated with lorlatinib include CNS effects, hyperlipidemia, atrioventricular block, pneumonitis, hypertension, hyperglycemia and significant drug interactions.
Product verification
The actual product packaging, manufacturer and authorization documentation should be checked before use or purchase.