Avastin plus 5-FU regimen OK'd as second-line therapy
Bevacizumab (Avastin, Genentech) has been approved by the FDA in combination with a 5-fluorouracil (5-FU)-based chemotherapy regimen as a second-line treatment for metastatic colorectal cancer. The phase III trial that led to the approval of the therapy evaluated 829 patients who received either bevacizumab plus FOLFOX4 (oxaliplatin, 5-FU, leucovorin) or FOLFOX4 alone and who were previously treated with irinotecan (Camptosar, Pfizer) and 5-FU as their initial therapy for metastatic disease or as adjuvant therapy. Results showed a 33% improvement in survival for the combination regimen. Median survival was 13 months versus 10.8 months.
Avastin plus 5-FU regimen OK'd as second-line therapy
Bevacizumab (Avastin, Genentech) has been approved by the FDA in combination with a 5-fluorouracil (5-FU)-based chemotherapy regimen as a second-line treatment for metastatic colorectal cancer. The phase III trial that led to the approval of the therapy evaluated 829 patients who received either bevacizumab plus FOLFOX4 (oxaliplatin, 5-FU, leucovorin) or FOLFOX4 alone and who were previously treated with irinotecan (Camptosar, Pfizer) and 5-FU as their initial therapy for metastatic disease or as adjuvant therapy. Results showed a 33% improvement in survival for the combination regimen. Median survival was 13 months versus 10.8 months. Bevacizumab is a vascular endothelial growth factor inhibitor that is also approved as a first-line treatment of metastatic colorectal cancer in combination with 5-FU-based chemotherapy.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
