Treats metastatic non-small cell lung cancer (NSCLC). NDA 210868, held by Pfizer. Lorlatinib.
As of Nov 13, 2026, NDA 210868 (Lorbrena), held by Pfizer, was first approved by FDA on Nov 2, 2018, with 6 approved supplements and 0 published complete response letters.
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.
| Mar 3, 2021 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Nov 2, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Lorbrena25MG · tablet;oral | Lorlatinib | RxReference drug |
| Lorbrena100MG · tablet;oral | Lorlatinib | RxReference drug |
| Jan 29, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Feb 18, 2025 | Supplement 6Manufacturing | Approved | |
| Mar 3, 2021 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Feb 26, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Jan 22, 2021 | Supplement 2Labeling · Standard review | Approved | |
| May 29, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Nov 2, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
