Treats relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic…. NDA 211155, held by Secura. Duvelisib.
As of Nov 14, 2026, NDA 211155 (Copiktra), held by Secura, was first approved by FDA on Sep 24, 2018, with 7 approved supplements and 0 published complete response letters.
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.
| Sep 24, 2018 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Oct 24, 2025 | Supplement 9REMS | Approved | |
| Jul 28, 2025 | Supplement 8REMS | Approved | |
| Jul 26, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Feb 2, 2022 | Supplement 6REMS | Approved | |
| Dec 17, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Sep 22, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Sep 26, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Sep 24, 2018 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 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
