# Bevacizumab

Bevacizumab (Avastin, Roche Registration GmbH) has 10 EU-approved indications in 6 tumour types. 1 needs a biomarker result: EGFR (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EGFR mutation | + erlotinib | 1st line, advanced | Non-squamous only |
| None | + platinum-based chemotherapy | 1st line, advanced | Non-squamous only |

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + capecitabine | 1st line, metastatic | Treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate; excluded if taxane and anthracycline-containing regimens received in the adjuvant setting within the last 12 months Ambiguous in the label (prior therapy): check the SmPC. |
| None | + paclitaxel | 1st line, metastatic | - |

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + fluoropyrimidine-based chemotherapy | Metastatic | - |

### Ovarian cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and paclitaxel | 1st line, advanced | FIGO stage IIIB, IIIC or IV |
| None | + carboplatin and gemcitabine or carboplatin and paclitaxel | 2nd line, advanced | After prior platinum-based therapy; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents; First recurrence of platinum-sensitive disease |
| None | + paclitaxel, topotecan, or pegylated liposomal doxorubicin | 2nd line, advanced | No more than two prior chemotherapy regimens; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents; Platinum-resistant disease |

### Cervical cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + paclitaxel and cisplatin or paclitaxel and topotecan | Advanced | Paclitaxel and topotecan for patients who cannot receive platinum therapy |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + interferon alfa-2a | 1st line, advanced | - |

## Products

### Avastin

- Company: Roche Registration GmbH
- Target: Anti-VEGF monoclonal antibody
- Class: VEGF/VEGFR (vascular endothelial growth factor / -receptor) inhibitors
- ATC: L01FG01
- EU approval: 12 Jan 2005
- Label revised: 27 Jan 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/avastin-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/avastin
- Biosimilars and generics: Mvasi, Aybintio, Abevmy, Zirabev, Alymsys, Avzivi, Vegzelma, Oyavas

Mechanism (SmPC section 5.1): Bevacizumab binds to VEGF, preventing its interaction with VEGFR-1 and VEGFR-2 to regress tumour vasculature and inhibit angiogenesis.

## Label wording

- **Bevacizumab** (Avastin), Colorectal cancer, metastatic: “Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Breast cancer, 1st line, metastatic: “Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Breast cancer, 1st line, metastatic: “Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Non-small cell lung cancer, 1st line, advanced: “Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Non-small cell lung cancer, 1st line, advanced: “Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Renal cell carcinoma, 1st line, advanced: “Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Ovarian cancer, 1st line, advanced: “Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. (See section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Ovarian cancer, 2nd line, advanced: “Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Ovarian cancer, 2nd line, advanced: “Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Cervical cancer, advanced: “Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/bevacizumab