Iressa Expanded Access Could Have Been Designed To Bolster Efficacy
Executive Summary
AstraZeneca's expanded access program for Iressa could have been designed to bolster efficacy data from pivotal trials, FDA Oncologic Drug Products Division Director Richard Pazdur, MD, suggested
You may also be interested in...
Wall Street Journal changes position on FDA reviewer
CDER Oncology Division Medical Review Officer Steven Hirschfeld, MD/PhD, praised in front page Wall Street Journal article Dec. 11 for his role in the approval of Sanofi-Synthelabo's anticancer treatment Eloxatin (oxaliplatin). The newspaper condemned the FDA oncologist a month earlier on its editorial page, calling Hirschfeld a "budding Albert Schweitzer" who disregards the welfare of cancer patients (1"The Pink Sheet" Oct. 27, p. 7)...
Wall Street Journal changes position on FDA reviewer
CDER Oncology Division Medical Review Officer Steven Hirschfeld, MD/PhD, praised in front page Wall Street Journal article Dec. 11 for his role in the approval of Sanofi-Synthelabo's anticancer treatment Eloxatin (oxaliplatin). The newspaper condemned the FDA oncologist a month earlier on its editorial page, calling Hirschfeld a "budding Albert Schweitzer" who disregards the welfare of cancer patients (1"The Pink Sheet" Oct. 27, p. 7)...
AstraZeneca Iressa Focus Is Sequential Therapy After INTACT Studies Fail
AstraZeneca is looking at Iressa monotherapy as an element of sequential chemotherapy regimens for solid tumors following the failure of the INTACT studies, VP-Medical Director of Oncology George Blackledge told an Aug. 19 conference call