Treats locally advanced or metastatic UC. BLA 761049, held by Emd Serono Inc. Avelumab.
As of Nov 13, 2026, BLA 761049 (Bavencio), held by Emd Serono Inc, was first approved by FDA on Mar 23, 2017, with 13 approved supplements and 0 published complete response letters.
BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1, 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. ( 1.2, 14.2 ) Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. ( 1.2, 14.2 ) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.2, 14.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2024 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Sep 6, 2023 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Jul 15, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 30, 2020 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2019 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Oct 19, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bavencio20MG/ML · injectable;injection | Avelumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2026 | Supplement 26Labeling · Standard review | Approved | |
| Jun 4, 2025 | Supplement 21Labeling · Standard review | Approved | |
| Nov 26, 2024 | Supplement 20Labeling · Standard review | Approved | |
| Oct 11, 2024 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2024 | Supplement 16Labeling · Standard review | Approved | |
| Sep 6, 2023 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Jul 15, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Jun 30, 2020 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2019 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Oct 19, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Apr 25, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Mar 23, 2017 | Original applicationNew molecular entity · Priority review | 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
