On Jan. 23, the FDA approved another version of second-line therapy for treating patients with metastatic colorectal cancer. Avastin was first approved for use as a first-line therapy in colorectal cancer in 2004, and Avastin with 5-FU based-chemotherapy was approved as a second-line option in 2006. This most recent indication allows Avastin (bevacizumab) to be used as a second-line therapy in conjunction with fluoropyrimidine-combination chemotherapy and either irinotecan or oxaliplatin. Fluoropyrimidines include Xeloda (capecitabine) and floxuridine, as well as 5-FU (fluorouracil). Avastin cannot be used as adjuvant therapy (additional treatment after the primary therapy).
Approval is based on a phase 3 trial with 820 patients with metastatic colorectal cancer who had progressed during or following treatment with Avastin-based chemotherapy. Patients were randomly assigned to “cross-over” chemotherapy plus Avastin or cross-over chemo alone. (Cross-over chemotherapy means that patients who had previously been treated with oxaliplatin-based chemo received irinotecan-based chemo in the study, and vice versa.)
Patients in the Avastin arm had a median overall survival of 11.2 months compared with 9.8 months for those in the chemotherapy-only arm. Progression-free survival was also improved by a median of 1.7 months for those in the Avastin arm.
The side effects in this study were similar to those seen in previous studies, which include fatigue, diarrhea and mouth sores.
Avastin can cost $88,000 per year and is also approved for treating advanced renal cell carcinoma, glioblastoma and non-squamous, non-small cell lung cancer.
For more information, visit avastin.com or call 877-428-2784.