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
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy. | approved | Sep 18, 2017 | ema |
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 15 hours 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 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04513951 | AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients(AVETRIC) | completed | Phase 2 | 62 | Gruppo Oncologico del Nord-OvestOTHER | 1 | Jan 9, 2025 | clinicaltrials |
| NCT04682587 | To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma |