Drug · Monoclonal Antibody
Avelumab
CI-DRUG-00000088Explore in graph →NCIt C116870 CHEMBL3833373 CIViC Approved
Regulatory
Approvals (12)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2024-10-11 (see label) | approved | Oct 11, 2024 | openfda |
| US FDA | — | Efficacy supplement 2023-09-06 (see label) | approved | Sep 6, 2023 | openfda |
| US FDA | — | Efficacy supplement 2022-07-15 (see label) | approved | Jul 15, 2022 | openfda |
| US FDA | — | Efficacy supplement 2020-06-30 (see label) | approved | Jun 30, 2020 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 51 | 12 | 18 | 223 | 12 | CA, EU, US | Mar 23, 2017 | Jan 31, 2013 |
| Malignant Kidney Neoplasm | Approved | Phase 3 | 5 | 1 | 3 | 15 | 1 | US | Mar 23, 2017 | Oct 26, 2015 |
| Malignant Breast Neoplasm | Phase3 | Phase 3 | 8 | 1 | 1 | 15 | 0 | — | — | Jun 17, 2016 |
| Malignant Bladder Neoplasm | Phase3 | Phase 3 | 5 | 0 | 2 | 14 | 0 |
Curated evidence
Clinical evidence (3)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 26918451
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| CD274 Expression2 | ||||||||
| Atezolizumab + Avelumab | ||||||||
Clinical trials
Trials with this intervention (235)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT02767063 | Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors (TKIs) in Chronic Phase Chronic Myelogenous Leukemia Patients in CCR (ACTIW)(ACTIW) | active not recruiting | Phase 1 / Phase 2 | 100 | Versailles HospitalOTHER | 1 | Sep 28, 2026 | clinicaltrials |
| NCT03076554 | A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy |