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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 < 0.0001).

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.

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