Treats advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with…. BLA 125477, held by Eli Lilly And Co. Ramucirumab.
As of Nov 14, 2026, BLA 125477 (Cyramza), held by Eli Lilly And Co, was first approved by FDA on Apr 21, 2014, with 16 approved supplements and 0 published complete response letters.
CYRAMZA is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
| Apr 7, 2025 | Supplement 49Efficacy (new indication or use) · Priority review | Approved | |
| Jan 27, 2025 | Supplement 48Efficacy (new indication or use) · Standard review | Approved | |
| May 29, 2020 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2019 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Apr 24, 2015 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2014 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Nov 5, 2014 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Cyramza100MG/10ML · injectable;injection | Ramucirumab | Rx |
| Cyramza500MG/50ML · injectable;injection | Ramucirumab | Rx |
| Aug 19, 2025 | Supplement 51Labeling · Standard review | Approved | |
| Apr 7, 2025 | Supplement 49Efficacy (new indication or use) · Priority review | Approved | |
| Jan 27, 2025 | Supplement 48Efficacy (new indication or use) · Standard review | Approved | |
| Mar 22, 2022 | Supplement 42Labeling · Standard review | Approved | |
| Jun 15, 2021 | Supplement 39Labeling · Standard review | Approved | |
| Jul 6, 2020 | Supplement 37Labeling · Standard review | Approved | |
| May 29, 2020 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 2020 | Supplement 36Labeling · Standard review | Approved | |
| Nov 5, 2019 | Supplement 35Labeling · Standard review | Approved | |
| Jul 31, 2019 | Supplement 33Labeling · Standard review | Approved | |
| May 10, 2019 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Nov 26, 2018 | Supplement 31Labeling · Standard review | Approved | |
| Aug 14, 2018 | Supplement 30Labeling · Standard review | Approved | |
| Apr 24, 2015 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2014 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Nov 5, 2014 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2014 | 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
