Treats relapsed or refractory peripheral T-cell lymphoma (PTCL). NDA 206256, held by Acrotech Biopharma. Belinostat.
As of Nov 13, 2026, NDA 206256 (Beleodaq), held by Acrotech Biopharma, was first approved by FDA on Jul 3, 2014, with 5 approved supplements and 0 published complete response letters.
Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Beleodaq500MG/VIAL · powder;intravenous | Belinostat | RxReference drug |
| Nov 19, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Apr 20, 2022 | Supplement 4Labeling · Standard review | Approved | |
| Jan 8, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Apr 12, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Apr 23, 2015 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jul 3, 2014 | 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
