Treats HER2-overexpressing breast cancer. BLA 761081, held by Pfizer Inc. Trastuzumab-Qyyp.
As of Nov 13, 2026, BLA 761081 (Trazimera), held by Pfizer Inc, was first approved by FDA on Mar 11, 2019, with 3 approved supplements and 1 published complete response letter.
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2019 | Original application | Approved |
| Letter | Product | Now |
|---|---|---|
| Apr 20, 2018 | Trazimera (PF-05280014)Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trazimera420MG · injectable;injection | Trastuzumab-Qyyp | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2025 | Supplement 17Labeling · Standard review | Approved | |
| May 7, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Jan 24, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Mar 11, 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
