ODAC
Absent mature data suggesting that Genentech's biomarker strategy would likely prove Avastin's efficacy in a subpopulation, ODAC members did not want to expose patients unnecessarily to a toxic agent for many years to come.
Despite Passionate Patient Accounts, FDA Sees No Evidence of 'Super-Responders' in Avastin Trials
Premium
If Genentech produces data showing substantial benefit in a subset of patients, "a new science-based indication could be approved," an FDA official said. "Until that time, it is not appropriate for the drug to continue to be approved for the treatment of breast cancer when the totality of the available data does not support such an approval."
A company spokesperson could not verify that the company will definitely discuss pharmacogenomics data on Avastin at the June 28-29 hearing.
ODAC Meeting on Accelerated Approval for Oncologics Raises Questions about Strategies for PGx Drugs
Premium
"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.
The protocol for the trial, which will study overall survival in Vectibix-treated chemorefractory patients with wild-type KRAS tumors, is currently being reviewed by the FDA.
Mar 17, 2010
Mar 4, 2009
Feb 4, 2009