This blog is committed to the entire field of oncology, health, wellness, evidence based medicine and patient engagement but this Avastin situation is too compelling of a complex story to gloss over. So for those of you with more than headline recap interest in the context as well as arguments on both sides of the issue, here some essential references.
On June 28 and 29, 2011, the Food and Drug Administration (FDA) conducted a hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw accelerated approval of the breast cancer indication for bevacizumab (Avastin). Genentech, Inc., and CDER were the parties to the hearing.
- Docket FDA-2010-N-0621 is available on Regulations.gov. All documents filed or posted in this matter are available for public review under Docket No. FDA-2010-N-0621 in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
- You may submit electronic or written comments to Regulations.gov. Comments must be submitted by July 28, 2011. You may also submit written comments to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
- Federal Register Notice
You may access video recordings of the hearing at the following links:
You may access transcripts of the hearing at the following links:
- Avastin Hearing, June 28: Full Transcript
- Avastin Hearing, June 28: Condensed Transcript
- Avastin Hearing, June 29: Full Transcript
- Avastin Hearing, June 29: Condensed Transcript