RPR TAXOTERE NDA RE-FILING IN 1997 IS TARGET FOLLOWING REJECTION BY FDA ADVISORY COMMITTEE; DOCETAXEL TOXICITY CONCERNS REQUIRE PHASE III STUDY
Executive Summary
Rhone-Poulenc Rorer will re-file its application for Taxotere (docetaxel) for breast and non-small cell lung cancers in early 1997, Senior VP-Pharmaceuticals Drug Development Gary Shearman, PhD, forecast at a press conference following the Dec. 13 advisory committee review of the application.