Treats chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). NDA 210563, held by Pharmacyclics LLC. Ibrutinib.
As of Nov 14, 2026, NDA 210563 (Imbruvica), held by Pharmacyclics LLC, was first approved by FDA on Feb 16, 2018, with 16 approved supplements and 0 published complete response letters.
IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. Adult patients with Waldenström’s macroglobulinemia (WM). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1.
| May 18, 2023 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2022 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2022 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 24, 2022 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2020 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2020 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jan 25, 2019 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2018 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 16, 2018 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Feb 16, 2018 | Original applicationNew dosage form · Priority review | Approved |
| Oct 21, 2025 | Supplement 20Labeling · Standard review | Approved | |
| Dec 20, 2024 | Supplement 19Labeling · Standard review | Approved | |
| May 9, 2024 | Supplement 18Labeling | Approved | |
| May 18, 2023 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2022 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2022 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 24, 2022 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| May 11, 2022 | Supplement 11Labeling · Standard review | Approved | |
| Dec 22, 2020 | Supplement 10Labeling · Standard review | Approved | |
| Dec 18, 2020 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Aug 7, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Apr 21, 2020 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Jul 15, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Jan 25, 2019 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2018 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 16, 2018 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Feb 16, 2018 | Original applicationNew dosage form · 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
