Sanofi-Synthelabo Eloxatine
Executive Summary
Company is beginning two Phase III trials for oxaliplatin as second-line treatment of metastatic colorectal cancer after Lilly gives up rights to oxaliplatin and returns product to Sanofi. Eloxatine received a negative recommendation for first-line treatment by FDA's Oncologic Drugs Advisory Committee in March, and FDA has told the company that "additional studies would be required prior to approval," Sanofi said
You may also be interested in...
Sanofi Eloxatin First-Line Colorectal Cancer Data Will Be Submitted By 2003
Sanofi-Synthelabo Eloxatin first-line data in advanced colonic and rectal adenocarcinoma will be submitted to FDA by the third quarter of 2003, following oxaliplatin's approval as second-line use
Sanofi Eloxatin First-Line Colorectal Cancer Data Will Be Submitted By 2003
Sanofi-Synthelabo Eloxatin first-line data in advanced colonic and rectal adenocarcinoma will be submitted to FDA by the third quarter of 2003, following oxaliplatin's approval as second-line use
Sanofi oxaliplatin NDA
Sanofi-Synthelabo submits final portion of rolling NDA for oxaliplatin as second-line treatment for advanced colorectal cancer June 24, company says. FDA's Oncologic Drugs Advisory Committee recommended against using the drug as first-line treatment in March 2000 (1"The Pink Sheet" Oct. 30, 2000, p. 32). FDA told a recent House hearing on ImClone that a randomized trial for a drug for the same indication as Erbitux "answered the question" of single-agent activity (2"The Pink Sheet" June 17, p. 7)...