Research and Markets: Approval Outlook for Avastin(R) As a Breast Cancer Treatment
Posted on: Monday, 3 March 2008, 12:01 CST
Research and Markets (http://www.researchandmarkets.com/reports/c84706) has announced the addition of "Approval Outlook for Avastin® as a Breast Cancer Treatment: A Survey of Fifty Oncologists" (Survey) to their offering.
Topic: Avastin use as a breast cancer treatment
- Impact of AVADO clinical trial data on timing of FDA decision
Respondent Type: Physicians
Specialties Covered: Oncology
Region: United States Only
Methodology
- Online survey, self-administered via a Panel Intelligence website
- Duration: 15 minutes
- Size: 50 respondents
- Fielding Dates: February 15, 2008 to February 16, 2008
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.
- - 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.
- - 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.
Inclusion Criteria
- Board-certified in Medical Oncology or Hematology/Oncology
- In practice between 2 and 30 years
- Spends at least 50% of professional time in clinical practice
- Seen at least 10 metastatic breast cancer patients over the past 3 months
- Currently use Avastin for treating breast cancer patients
Company mentioned:
- Genentech
For more information visit http://www.researchandmarkets.com/reports/c84706
Source: Business Wire
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