Approval Outlook for Avastin� as a Breast Cancer Treatment

A Survey of Fifty Oncologists

February 2008
Price:  $1500

Deliverable:  Survey with key findings.

Study Description:

Objectives:

To conduct a brief survey among oncologists who are currently using Avastin to treat breast cancer to gauge their opinion of the AVADO trial and assess its potential impact on the FDA review of Avastin in the treatment of breast cancer that is to occur on February 23, 2008.

�    To gauge the significance of potential reasons why Avastin did not receive a recommendation for approval for the treatment of breast cancer by the FDA�s Oncologic Drugs Advisory Committee in December 2007.

�    To elicit physician opinion about whether the AVADO trial�s progression-free survival (PFS) data will be sufficient for FDA approval or if overall survival (OS) data will be required.

�    To determine what other data, if any, will be required for FDA approval of Avastin for the treatment of breast cancer.

�    To assess whether the results of the AVADO study provide confirmation of Avastin�s efficacy and safety in patients who have not received prior chemotherapy for their locally recurrent or metastatic HER2-negative breast cancer.

o         Can the results of the AVADO trial be extrapolated to support the results of the E2100 trial and the FDA license application?

�    To obtain physician opinion about whether Avastin will receive FDA approval on February 23, 2008 for the treatment of breast cancer.

o         Opinion about the potential for a delayed decision will also be assessed.

�    To acquire physician opinion about whether or not the results of the RIBBON-1 trial will be required by the FDA prior to approving Avastin for the treatment of breast cancer.

Companies and Products Mentioned in This Report: 

Inclusion Criteria and Respondent Demographics:

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