Bevacizumab

Bevacizumab (Avastin, Roche Registration GmbH) has 10 EU-approved indications in 6 tumour types. 1 needs a biomarker result: EGFR (1).
Approved indications of Bevacizumab
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
EGFR mutation
+ erlotinib
1L
advanced
Non-squamous only
None
+ platinum-based chemotherapy
1L
advanced
Non-squamous only
Breast cancer2
None
+ capecitabine
1L
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
None
+ paclitaxel
1L
metastatic
None
Colorectal cancer1
None
+ fluoropyrimidine-based chemotherapy
Any line
metastatic
None
Ovarian cancer3
None
+ carboplatin and paclitaxel
1L
advanced
FIGO stage IIIB, IIIC or IV
None
+ carboplatin and gemcitabine or carboplatin and paclitaxel
2L
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
2L
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 cancer1
None
+ paclitaxel and cisplatin or paclitaxel and topotecan
Any line
advanced
Paclitaxel and topotecan for patients who cannot receive platinum therapy
Renal cell carcinoma1
None
+ interferon alfa-2a
1L
advanced
None
Full text of section 4.1 (therapeutic indications)

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. 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. 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. 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. 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). Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. 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). 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. 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). 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).

Label history

74 changes to the Avastin label since 2005, 12 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes