FDA Approves Avastin for New Second-Line Use

For patients with metastatic colorectal cancer, the Food and Drug Administration (FDA) has approved a new use of Avastin® (bevacizumab): It can be continued as part of ‘second-line’ combination therapy, even if it was used in first-line therapy.

When stage IV cancer progresses despite use of Avastin plus either FOLFOX (5FU plus Eloxatin® or oxalyplatin) or FOLFIRI (5FU plus Camptosar® or irinotecan)-based chemotherapy, the FDA has now approved continued use of Avastin when second-line treatment switches to the other chemotherapy.

Avastin is a monoclonal antibody (a “targeted drug”) that helps prevent a cancer from stimulating growth of new blood-vessels that then help the tumor get bigger.

The FDA’s approval is based on a large, randomized Phase III trial which showed that median overall survival was 11.2 months when patients continued Avastin along with the second-line chemotherapy, compared to a 9.8-month median survival with just the second-line chemotherapy without Avastin. Participants in the trial averaged about 63 years old, and were able to carry out normal activities or at least housework or office work (i.e., ECOG performance status of 0-1).

There was no significant increase in adverse events (such as worse side effects) in those continuing Avastin, versus those who stopped the drug for second-line treatment.

FDA approval for the new use clears the way for insurers to cover the drug’s use, which averages roughly $5,100 a month.

Sources: Jan. 25, 2013 FDA press release; “Avastin Wins New Colorectal Cancer Indication,” Jan. 24 2013 MedPage Today ; “Genentech’s Avastin approved for wider use in colorectal cancer,” Jan. 24 San Francisco Business Times.

Disclosure: Fight Colorectal Cancer accepts  unrestricted educational grants and charitable donations from Genentech, the manufacturers of Avastin. Fight Colorectal Cancer has ultimate control over website content.