Lorbrexen is identified on this website as a product containing 100 mg of lorlatinib. The product-specific manufacturer and regulatory authorization require verification.
Lorlatinib is an oral ALK tyrosine kinase inhibitor used for selected patients with ALK-positive NSCLC.
Current U.S. labeling covers adults with metastatic ALK-positive NSCLC identified using an FDA-approved test.
Lorlatinib is generally classified as a targeted anticancer therapy and ALK tyrosine kinase inhibitor rather than conventional cytotoxic chemotherapy.
It blocks abnormal ALK kinase signaling and was developed to retain activity against several ALK resistance mutations.
Yes. Lorlatinib was specifically developed to penetrate the blood-brain barrier, and clinical studies have demonstrated intracranial activity.
The current U.S. labeled dose is 100 mg orally once daily.
Current U.S. labeling allows LORBRENA to be taken with or without food.
Current U.S. LORBRENA labeling identifies 25 mg and 100 mg tablets.
Common adverse reactions include edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects and cough.
Yes. Hypercholesterolemia and hypertriglyceridemia are characteristic laboratory abnormalities associated with lorlatinib.
Yes. CNS effects can include cognitive, mood, speech, sleep and mental-status changes, as well as seizures and psychotic effects.
Interstitial lung disease and pneumonitis are recognized serious risks associated with lorlatinib.
Yes. CYP3A inducers and inhibitors can significantly affect lorlatinib exposure, and strong CYP3A inducers are contraindicated.
Lorlatinib carries embryo-fetal toxicity considerations. Pregnancy should be discussed with the treating healthcare professional.
The current U.S. prescribing information advises against breastfeeding during LORBRENA treatment.
Yes. The U.S. indication requires confirmation of an ALK-positive tumor using an FDA-approved test.
LORBRENA is the U.S. reference brand, while Lorviqua is the European brand.
They should not automatically be described as the same commercial product. Product-specific manufacturer, formulation and regulatory information must establish the relationship.
Pfizer states that lorlatinib was discovered and developed by Pfizer scientists.
CROWN is a phase III randomized study comparing lorlatinib with crizotinib in previously untreated advanced ALK-positive NSCLC.
At five years, progression-free survival was 60% with lorlatinib and 8% with crizotinib, while median PFS was not reached with lorlatinib.