BLA 125557, held by Amgen. Blinatumomab.
As of Nov 13, 2026, BLA 125557 (Blincyto), held by Amgen, was first approved by FDA on Dec 3, 2014, with 22 approved supplements and 0 published complete response letters.
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2024 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Jun 20, 2023 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | |
| Jun 20, 2023 | Supplement 23Efficacy (new indication or use) | Approved | |
| Mar 11, 2021 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Mar 11, 2021 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 29, 2018 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jul 11, 2017 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2016 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Dec 3, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Blincyto35MCG · injectable;injection | Blinatumomab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2025 | Supplement 32Labeling · Standard review | Approved | |
| Apr 29, 2025 | Supplement 31Labeling · Standard review | Approved | |
| Dec 17, 2024 | Supplement 30Labeling · Standard review | Approved | |
| Jun 14, 2024 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Feb 8, 2024 | Supplement 29Labeling · Standard review | Approved | |
| Jun 20, 2023 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | |
| Jun 20, 2023 | Supplement 23Efficacy (new indication or use) | Approved | |
| Dec 5, 2022 | Supplement 25REMS | Approved | |
| Feb 18, 2022 | Supplement 21Labeling · Standard review | Approved | |
| Mar 11, 2021 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Mar 11, 2021 | Supplement 19REMS | Approved | None posted |
| Mar 11, 2021 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 20, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Apr 18, 2019 | Supplement 16REMS | Approved | |
| Apr 18, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Apr 10, 2018 | Supplement 14REMS | Approved | |
| Mar 29, 2018 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Nov 30, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Jul 11, 2017 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| May 3, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Aug 30, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Aug 30, 2016 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Dec 3, 2014 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
