Genentech Inc, recently announced that the US Food and Drug Administration (FDA) approved bevacizumab(Drug information on bevacizumab) (Avastin) in combination with intravenous fluorouracil(Drug information on fluorouracil) (5-FU)-based chemotherapy for second-line metastatic colorectal cancer. Bevacizumab is also approved as a first-line treatment of metastatic colorectal cancer (CRC) in combination with intravenous 5-FU-based chemotherapy.
The approval is based on results of a randomized, controlled, multicenter phase III trial (E3200) of 829 patients with advanced or metastatic CRC who had received previous treatment with irinotecan(Drug information on irinotecan) and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received bevacizumab plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin [Eloxatin]/5‑FU/leucovorin) had a 25% reduction in the risk of death (hazard ratio = 0.75), the primary endpoint, which is equivalent to a 33% improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving bevacizumab plus FOLFOX4 was 13.0 months, compared to 10.8 months for those receiving FOLFOX4 alone.