Treats relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at…. BLA 761051, held by Kyowa Kirin. Mogamulizumab-Kpkc.
As of Nov 13, 2026, BLA 761051 (Poteligeo), held by Kyowa Kirin, was first approved by FDA on Aug 8, 2018, with 4 approved supplements and 0 published complete response letters.
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Poteligeo20MG/5ML · injectable;injection | Mogamulizumab-Kpkc | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2026 | Supplement 25Labeling · Standard review | Approved | |
| Jan 21, 2025 | Supplement 18Labeling · Standard review | Approved | |
| Mar 30, 2022 | Supplement 15Labeling · Standard review | Approved | |
| Jul 8, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Aug 8, 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
