Lorbrexen is identified on this website as a product containing 100 mg of lorlatinib. The specific manufacturer and regulatory authorization for the Lorbrexen-branded product require verification.
Lorlatinib is a targeted oral anticancer medicine classified as an ALK tyrosine kinase inhibitor. It was developed as a next-generation ALK inhibitor with activity against a range of ALK resistance mutations and the ability to reach the central nervous system.
Product identity
| Attribute | Information |
|---|---|
| Product | Lorbrexen |
| Generic name | Lorlatinib |
| Active substance | Lorlatinib |
| Stated strength | 100 mg |
| Dosage form | [Information requires verification] |
| Route | Oral, subject to product documentation |
| Drug class | ALK tyrosine kinase inhibitor |
| Reference U.S. brand | LORBRENA |
| European brand | Lorviqua |
| Original developer | Pfizer |
| Lorbrexen manufacturer | Everest Pharmaceuticals Ltd. |
What does 100 mg mean?
The 100 mg designation identifies the amount of lorlatinib contained in the dosage unit, assuming the product’s stated strength is confirmed by its labeling.
The current U.S. LORBRENA regimen is 100 mg orally once daily for patients who meet the labeled indication. The U.S. product is available in 25 mg and 100 mg tablets.
Lorbrexen and LORBRENA
LORBRENA is the Pfizer reference brand used in the United States. Pfizer received the original U.S. approval for lorlatinib in 2018 and later received approval for first-line use in metastatic ALK-positive NSCLC in 2021.
Lorbrexen should not automatically be described as the same commercial product as LORBRENA. The active ingredient may be the same, but manufacturer, formulation, excipients, packaging, authorization and supply-chain arrangements must be established separately.
Lorlatinib and ALK-positive NSCLC
Lorlatinib is intended for cancers driven by ALK alterations. The FDA indication specifically requires ALK-positive metastatic NSCLC detected using an FDA-approved test.
Safety considerations
Lorlatinib requires monitoring because treatment can affect neurological function, lipid levels, cardiac conduction, blood pressure, blood glucose and pulmonary health. Drug interactions are also important, particularly those involving CYP3A.