Avastin ODAC: Biostats
The reason there were two biostats guys on the panel is that the trial results were a mess. A lot of missing scans (so how do you really know when a patient progressed?) and a very high discordance rate between the IRF and the investigator reported numbers. The missing scans were not as bad as when IMCL got the RTF letter from the FDA, but it was an issue.
"ECOG and IRF were discordant for 368 (181 in PAC arm and 187 in PAC/BV arm) patients, which accounts for 51.0% of the 722 patients."
During the Q&A, the tone of the questions from the panel were very negative. I thought Avastin would only get 2 postive votes based on the questions asked by the panel members. Also, Eric Winer (speaking on behalf of DNA)and Maha Hussain got in to it one time, with Dr. Hussain getting the better, IMO.
Winer brought up that Ixabepilone was approved (albeit for 2/3rd line MBC) with a smaller benefit and a lot of PN toxicity. Hussain responded by saying it was a weak argument to use one "substandard" trial to justify another "substandard" trial. Winer then sat down.
Hussain, then turned to Padzur and said she wished the panel had the opportunity to review Ixabepilone prior to the FDA approving it. My take was that she thinks very little of the Ixabepilone data.
