Treats metastatic NSCLC. BLA 761034, held by Genentech Inc. Atezolizumab.
As of Nov 13, 2026, BLA 761034 (Tecentriq), held by Genentech Inc, was first approved by FDA on May 18, 2016, with 41 approved supplements and 0 published complete response letters.
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1, 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2026 | Supplement 65Efficacy (new indication or use) · Priority review | Approved | |
| May 15, 2026 | Supplement 61Efficacy (new indication or use) · Priority review | Approved | |
| Oct 2, 2025 | Supplement 58Efficacy (new indication or use) · Priority review | Approved | |
| Dec 9, 2022 | Supplement 47Efficacy (new indication or use) · Priority review | Approved | |
| Dec 2, 2022 | Supplement 50Efficacy (new indication or use) · Priority review | Approved | |
| Oct 15, 2021 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Oct 6, 2021 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Apr 13, 2021 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 36Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 34Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2020 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2020 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Sep 30, 2020 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2020 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| May 29, 2020 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2020 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Dec 3, 2019 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2019 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2019 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2019 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Mar 8, 2019 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Dec 6, 2018 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Jul 2, 2018 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jun 19, 2018 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Jun 14, 2018 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Apr 30, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 17, 2017 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2016 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tecentriq1200MG/20ML · injectable;injection | Atezolizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2026 | Supplement 65Efficacy (new indication or use) · Priority review | Approved | |
| May 15, 2026 | Supplement 61Efficacy (new indication or use) · Priority review | Approved | |
| May 12, 2026 | Supplement 62Labeling · Standard review | Approved | |
| Nov 17, 2025 | Supplement 59Labeling · Standard review | Approved | |
| Oct 2, 2025 | Supplement 58Efficacy (new indication or use) · Priority review | Approved | |
| Aug 18, 2025 | Supplement 57Labeling · Standard review | Approved | |
| Apr 22, 2024 | Supplement 53Labeling · Standard review | Approved | |
| May 12, 2023 | Supplement 51Labeling · Standard review | Approved | |
| May 12, 2023 | Supplement 49Labeling · Standard review | Approved | |
| Dec 9, 2022 | Supplement 47Efficacy (new indication or use) · Priority review | Approved | |
| Dec 2, 2022 | Supplement 50Efficacy (new indication or use) · Priority review | Approved | |
| Jan 21, 2022 | Supplement 43Labeling · Standard review | Approved | |
| Oct 15, 2021 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Oct 6, 2021 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Apr 13, 2021 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 36Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 34Efficacy (new indication or use) · Priority review | Approved | |
| Feb 17, 2021 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2020 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2020 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2020 | Supplement 20Labeling · Standard review | Approved | |
| Sep 30, 2020 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2020 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| May 29, 2020 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2020 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Dec 3, 2019 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2019 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2019 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2019 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Mar 8, 2019 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Dec 6, 2018 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Jul 2, 2018 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jun 26, 2018 | Supplement 11Labeling · Standard review | Approved | |
| Jun 19, 2018 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Jun 14, 2018 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Apr 30, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 13, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Apr 17, 2017 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2016 | 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