Treats anaplastic lymphoma kinase (ALK)-positive metastatic … lung cancer (NSCLC). NDA 208772, held by Takeda Pharms USA. Brigatinib.
As of Nov 13, 2026, NDA 208772 (Alunbrig), held by Takeda Pharms USA, was first approved by FDA on Apr 28, 2017, with 5 approved supplements and 0 published complete response letters.
ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2020 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 21, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alunbrig30MG · tablet;oral | Brigatinib | RxReference drug |
| Alunbrig90MG · tablet;oral | Brigatinib | RxReference drug |
| Alunbrig180MG · tablet;oral | Brigatinib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 2021 | Supplement 12Labeling · Standard review | Approved | |
| May 22, 2020 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 21, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 2, 2017 | Supplement 2Manufacturing | Approved | None posted |
| Apr 28, 2017 | 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
