Quick answers
- What is Lorlatinib used for?
- The FDA-approved label (Lorbrena, Pfizer Laboratories Div Pfizer Inc, June 26, 2026) says: “LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lorlatinib have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lorlatinib?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 15, 2026). Ask your pharmacist about alternatives.
- Has Lorlatinib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lorlatinib?
- 2 companies list prescription products of Lorlatinib in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc and U.S. Pharmaceuticals.
What Lorlatinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. …
— FDA label: Lorbrena, Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Lorbrena |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pfizer Laboratories Div Pfizer Inc2 products
- U.S. Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210868 LORBRENA | Pfizer | November 2, 2018 | 6, latest January 29, 2026 2026: Labeling · 2025: Manufacturing (CMC) · 2021: Efficacy |
Shortage status
To be discontinued · updated June 15, 2026 · first posted June 15, 2026
| Product | Lorbrena, Tablet, 25 mg; 120 tablets bottle with a child-resistant closure (NDC 0069-0227-03) |
|---|---|
| Company | Pfizer Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2103169, 2103175, 2103177, 2103179 |
|---|---|
| SPL set ID of the quoted label | 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d |
| FDA labels (SPL) | 2 |
| FDA applications | NDA210868 |
| Active ingredients (FDA) | LORLATINIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lorbrena, Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →