Treats HER2-overexpressing breast cancer. BLA 761073, held by Amgen Inc. Trastuzumab-Anns.
As of Nov 13, 2026, BLA 761073 (Kanjinti), held by Amgen Inc, was first approved by FDA on Jun 13, 2019, with 2 approved supplements and 1 published complete response letter.
KANJINTI is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. ( 1.1, 1.2 ) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1, 2.2 ). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2019 | Original application | Approved |
| Letter | Product | Now |
|---|---|---|
| May 25, 2018 | Kanjinti (ABP 980)Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kanjinti420MG · vial; multidose | Trastuzumab-Anns | Rx |
| Kanjinti150MG · vial;single-dose | Trastuzumab-Anns | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2024 | Supplement 10Biosimilar | Approved | |
| Oct 25, 2019 | Supplement 1 | Approved | |
| Jun 13, 2019 | Original application | 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
