First anti-angiogenesis treatment approved for treating cancer
The US FDA has approved Genentech's Avastin (bevacizumab) to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treat-ment for patients with first-line metastatic cancer of the colon or rectum.
The US FDA has approved Genentech's Avastin (bevacizumab) to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treat-ment for patients with first-line metastatic cancer of the colon or rectum.
Avastin is the first FDA-approved therapy designed to inhibit angiogenesis and was filed under the FDA's Fast Track programme. The approval is based on data from two trials. The pivotal trial was a large, placebo-controlled, randomised study that demonstrated a prolongation in the median survival of patients treated with Avastin plus the IFL (5-FU/Leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared with patients treated with the IFL chemotherapy regimen alone.
In addition, this study demonstrated an improvement in progression-free survival (PFS) of more than four months. The survival and PFS results observed when Avastin is added to first-line chemotherapy are the longest ever reported in a randomised, Phase III study of patients with metastatic colorectal cancer.
'This marks an important shift in the treatment of metastatic colorectal cancer, with the approval of an innovative treatment based on elegant science that targets cancer in an entirely new way,' said Dr Arthur D. Levinson, Genentech's chairman and ceo. 'We're pleased that patients diagnosed with metastatic colorectal cancer today have a new treatment option.'