You are here

FDA Approves New Use for Bevacizumab (Avastin) in Metastatic Colorectal Cancer

Drug can be continued as second-line treatment after failure of first-line therapy (Jan. 24)

The FDA has approved a new use for bevacizumab (Avastin, Roche) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for patients with metastatic colorectal cancer (mCRC). The new indication will allow patients who received bevacizumab plus irinotecan- or oxaliplatin-containing chemotherapy as first-line treatment for mCRC to continue to receive the drug plus a different irinotecan- or oxaliplatin-containing chemotherapy (second-line treatment) after their cancer worsens.

The approval is based on positive results from the phase III ML18147 study, which showed that patients who continued to receive a bevacizumab-based regimen after their cancer worsened lived longer than patients who switched to chemotherapy alone. The risk of death was reduced by 19% in patients who received bevacizumab in combination with standard chemotherapy as both first- and second-line treatment compared with those who received chemotherapy (hazard ratio [HR] = 0.81; P = 0.0057). The median overall survival was 11.2 months for the bevacizumab group versus 9.8 months for the chemotherapy group. The risk of the cancer worsening or death (progression-free survival) was reduced by 32% in the bevacizumab group (HR = 0.68; P

Avastin (bevacizumab) is the only biologic medicine approved by the FDA as initial treatment for patients with mCRC in combination with intravenous fluorouracil (5FU)-based chemotherapy; as a treatment for patients whose cancer has worsened after chemotherapy alone; and now as a treatment for patients whose cancer has worsened after initial therapy with a bevacizumab-based regimen. Bevacizumab is not indicated for adjuvant treatment of colon cancer.

An independent blood supply is critical for a tumor to grow beyond a certain size (2 mm) and for metastasis to occur. Tumors develop their own blood supply (angiogenesis) by releasing vascular endothelial growth factor (VEGF) — a key driver of tumor growth. Bevacizumab is an antibody that targets and inhibits VEGF for tumor control.

Source: Roche; January 24, 2013.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug