Treats HER2-overexpressing breast cancer. BLA 761091, held by Celltrion Inc. Trastuzumab-Pkrb.
As of Nov 13, 2026, BLA 761091 (Herzuma), held by Celltrion Inc, was first approved by FDA on Dec 14, 2018, with 4 approved supplements and 1 published complete response letter.
HERZUMA 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 |
|---|---|---|---|
| May 16, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2018 | Original application | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 30, 2018 | CT-P6Facility Inspections, Product Quality, Clinical Pharmacology | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Herzuma420MG · injectable;injection | Trastuzumab-Pkrb | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2025 | Supplement 35Labeling · Standard review | Approved | |
| Nov 13, 2024 | Supplement 33Biosimilar · Standard review | Approved | |
| May 16, 2019 | Supplement 1Manufacturing · Standard review | Approved | |
| May 16, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2018 | 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
