Safety First
This article was originally published in RPM Report
Executive Summary
The opening exchange between Covington & Burling attorney Paul Schmidt, representing Genentech, and FDA Division of Biologic Oncology Director Patricia Keegan, during the first day of the Avastin withdrawal hearing. (Excerpted by The RPM Report from FDA’s official transcript.)
This is the opening exchange between Covington & Burling attorney Paul Schmidt, representing Genentech, and FDA Division of Biologic Oncology Director Patricia Keegan, during the first day of the Avastin withdrawal hearing. (Excerpted by The RPM Report from FDA's official transcript.)
MR. SCHMIDT: CDER's presentation points out that there are very respectful but vigorous areas of disagreement between CDER and Genentech on what the data shows. But we believe there are also areas of agreement between the two sides, and that's where I'd like to start by asking some questions, where we agree on what the data shows and what conclusions we draw from the data. And I'd like to start with safety.
When we talk about safety, am I correct that CDER agrees that the label fairly describes the safety for Avastin?
DR. KEEGAN: Yes.
MR. SCHMIDT: And that safety has not materially changed from the time of accelerated approval.
DR. KEEGAN: Yes.
MR. SCHMIDT: So what we're talking about today when we're talking about safety is we're not talking about a change in the safety since the time of accelerated approval, we're talking about an initial showing of benefit in E2100 that justified that safety profile, and CDER no longer believes that that safety profile is appropriate in light of its current views on the efficacy of Avastin.
DR. KEEGAN: Yes.