Editors Note: As a followup on the FDA’s controversial 2011 decision to revoke its approval of Avastin for late-stage breast cancer treatment, we are reprinting this recent update from fameds.org.
FREEDOM OF ACCESS TO MEDICINES NEWSLETTER #20
April 12, 2012
OPPORTUNITY FOR AVASTIN PATIENTS TO ENROLL IN GENETIC STUDY
Dear FAMEDS Supporters,
It’s been many months since we last communicated as all has been quiet on the Avastin front. Due to your good efforts, all Avastin patients with metastatic breast cancer at the time of the FDA’s decision continue to receive Avastin and insurance coverage through private insurance companies and Medicare.
Despite the FDA’s decision last year, Genentech, the manufacturer of Avastin, still appears firmly committed to researching the use of Avastin for metastatic breast cancer and a new study just opened a few weeks ago.
Genentech has partnered with 23andMe, a personal genetics company, on a first of its kind, pilot observational study (InVite) to learn if a person’s genes could play a role in how they respond to Avastin in the treatment of metastatic breast cancer. More information about the study, such as eligibility, how to enroll and information about patient privacy are available at:
Eligibility includes being treated with Avastin at any point in 2010 and/or 2011. Genentech hopes to recruit 1,000 people to participate in the study who will be asked to send a saliva (spit) sample for genetic analysis, potentially provide a blood sample, and participate in an online survey to answer questions about their breast cancer and experience with Avastin.
The primary goals of this study are to determine if people are willing to participate in a web-based research model and to determine the effectiveness of gathering information through this method. In addition, Genentech hopes to analyze genetic information from study participants to determine if there are any genetic differences between people who do well on Avastin and those who do not.
This InVite study is not replacing the ongoing search for a biomarker through the Avastin clinical development program. Genentech still plans to initiate MERiDiAN this year, the Phase III trial discussed with the FDA that will evaluate Avastin plus paclitaxel in people with HER2-negative mBC and will also evaluate VEGF-A as a potential predictive biomarker for efficacy with Avastin.
While we have not heard of any problems, if you or someone you know has any questions or concerns about insurance coverage about Avastin, please call Genentech’s Access Solutions Group at (866) 4 ACCESS and the team of specialists may be able to help. If there are any new developments on the Avastin front please be assured that we will keep you informed.
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