InCrowd question to oncologists regarding the use of Avastin in metastatic breast cancer.

1. InCrowd, Inc.
Avastin in Metastatic Breast Cancer
Query of Oncologists Treating mBC, NSCLC, CRC
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June 2011
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2. FDA Hearing: Avastin in Metastatic Breast Cancer
 February of 2008 the Food and Drug Administration (FDA) granted
accelerated conditional approval of Avastin for the treatment of metastatic
breast cancer (mBC)
 December 2010 FDA announced plans to revoke approval for mBC as
confirmatory studies AVADO and RIBBON1 failed to verify clinical benefit in
the mBC indication and demonstrated an unfavorable risk benefit analysis
 Failed to substantiate the magnitude of PFS in E2100
 Failed to show any improvement in overall survival
 No data showing improvement in quality of life
 Avastin in combination with chemotherapy has modest effect in PFS balanced against its
risks of serious & life-threatening toxicities
 June 28-29, 2011 first of its kind, open to the public FDA hearing on approval
status of Avastin in mBC
 Initial 2 hours of hearing to be testimony from 35 members of the public
 Oncology community divided over the issue of Avastin
treatment in mBC

3. InCrowd Asked Oncologists
 Prior to the start of the hearing InCrowd asked oncologists treating mBC,
NSCLC and CRC to weigh in on the use of Avastin in mBC…
Beginning tomorrow June 28, 2011 there will be a two day public
FDA hearing regarding the use of bevacizumab (Avastin) in
metastatic breast cancer. Please review the statements below
and select those that reflect your thinking on the subject.
 Oncologists nearly evenly split regarding Avastin indication and hearing
 Maintain Avastin indication was selected 18 times
 Remove Avastin indication was selected 14 times
 11 oncologists support an open hearing
 15 oncologists support a hearing closed to the public

4. Oncologists Weigh In on Avastin Use in Metastatic Breast Cancer
Maintain Indication
Remove Indication
Confirmatory Trials
Maintain Access
Confirmatory Trials
Diagnostic Test
Hearing Open to Public
Hearing Closed
to Public
18/45%
14 /35%
19/47.5%
14/35%
11/27.5%
15/37.5%
1. Avastin is an important option for women with metastatic breast cancer and should remain FDA-approved
2. The FDA should remove the breast cancer indication for Avastin as the new studies did not demonstrate the drug was helping women
live longer or adequately delay the progression of their cancers, while at the same time exposing them to dangerous side effects
3. If additional confirmatory trials are conducted, women should have continued access to Avastin with paclitaxel (Taxol) during that time
and the FDA indication should be maintained
4. Any confirmatory clinical trials must include the development of a test to determine which cancers are most likely to respond to Avastin
5. The hearing should be open for public comment and oral presentations by patients as this could further inform the FDA decision
6. The hearing should not be open for public comment and oral presentations from patients as this is merely a distraction and the decision
should be made on clinical data alone
Q. Beginning tomorrow June 28, 2011 there will be a two day public FDA hearing regarding the use of bevacizumab (Avastin) in
metastatic breast cancer. Please review the statements below and select those that reflect your thinking on the subject
Number of times selected / % of sample n=40

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