Treats HER2-overexpressing breast cancer. BLA 761346, held by Accord Biopharma Inc.. Trastuzumab-Strf.
As of Nov 13, 2026, BLA 761346 (Hercessi), held by Accord Biopharma Inc., was first approved by FDA on Apr 25, 2024, with 1 approved supplement and 0 published complete response letters.
Hercessi TM 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 |
|---|---|---|---|
| Apr 25, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hercessi150MG · injectable;injection | Trastuzumab-Strf | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 2024 | Supplement 1Manufacturing | Approved | |
| Apr 25, 2024 | 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
