Treats metastatic colorectal cancer (mCRC). BLA 125418, held by Sanofi Aventis US. Ziv-Aflibercept.
As of Nov 13, 2026, BLA 125418 (Zaltrap), held by Sanofi Aventis US, was first approved by FDA on Aug 3, 2012, with 8 approved supplements and 0 published complete response letters.
ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2015 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Aug 3, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zaltrap4MG · injectable; injection | Ziv-Aflibercept | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2023 | Supplement 54Labeling · Standard review | Approved | |
| Jun 5, 2020 | Supplement 47Labeling · Standard review | Approved | |
| Mar 11, 2020 | Supplement 46Labeling · Standard review | Approved | |
| Nov 25, 2019 | Supplement 45Labeling · Standard review | Approved | |
| Jun 24, 2016 | Supplement 39Labeling · Standard review | Approved | |
| Mar 9, 2016 | Supplement 37Labeling · Standard review | Approved | |
| Sep 17, 2015 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Oct 25, 2013 | Supplement 20Labeling · Standard review | Approved | |
| Aug 3, 2012 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
