FDA approves Avastin for treatment of metastatic cervical cancer
- Avastin (bevacizumab) was approved in less than four months under the FDA’s priority review program.
- Avastin is intended to be used in combination with either paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
- Phase III trials showed an overall survival advantage for the Avastin-based treatment combination versus chemotherapy alone --16.8 months versus 12.9 months.
On July 17, Biopharma Dive reported that Avastin was being fast-tracked by the FDA. At that point, an FDA decision was expected by October.
But the decision came two months early based on strong evidence of Avastin’s efficacy as an add-on treatment for advanced metastatic cancer. In a study of 452 patients with recurrent persistent or metastatic cervical cancer, there was a 30% overall survival advantage associated with the Avastin-based treatment regimen.