Date: 2013-01-30
Type of information: Granting of a Market Authorisation in the US
Product name: Avastin®
Compound: bevacizumab
Therapeutic area: Cancer - Oncology
Action mechanism: monoclonal antibody. Avastin® is an antibody that precisely targets and inhibits vascular endothelial growth factor (VEGF)for continuous tumour control. Avastin’s VEGF inhibition allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.
Company: Roche (Switzerland)
Disease: combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the second line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin®-containing regimen
Latest news:
- • On January 24, 2013, Roche has announced that the FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). Avastin® in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is now indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin®-containing regimen. The approval is based on positive results from the Phase III ML18147 study, which were presented at the 2012 American Society of Clinical Oncology annual meeting and showed that people who continued to receive an Avastin®-based regimen after their cancer worsened lived longer than people who switched to chemotherapy alone.
Avastin® is the only biologic medicine approved by the FDA to treat people with mCRC in combination with intravenous 5FU-based chemotherapy as an initial treatment, as treatment for people whose cancer has worsened after chemotherapy alone, and now as a treatment for people whose cancer has worsened after initial treatment with an Avastin-based regimen. This is the third approval for Avasti®n in mCRC based on improved overall survival. Avastin® is not indicated for adjuvant treatment of colon cancer.
Avastin® is approved in Europe in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum. The European product information has been updated based on the positive results of the Phase III ML18147 study with an implementation date of December 12, 2012 allowing people with mCRC who received Avastin® plus chemotherapy as a first-line treatment to continue to receive Avastin plus chemotherapy after their cancer worsens as part of their second-line treatment.
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Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-01-24
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
