Table 3.

Disparate regulatory approvals.

Drug	Date, indication	Endpoint	Notes
Trabectedin  Europe–Other Non-US	September 2009, EC–approved for platinum-sensitive recurrent ovarian cancer	Primary outcome measures: PFS assessed by independent radiology review Secondary outcome measures: OS RR, PK And safety	April 2011, J&J voluntarily withdraws trabectedin US NDA
Bevacizumab  Europe–Other Non-US	2012,1st Line in combination with standard chemotherapy (carboplatin & paclitaxel) following surgery with advanced ovarian cancer.	PFS	2 phase III studies 19.3 months vs 16.9 months 14.7 months vs 10.6 months

Reprinted from Gynecol Oncol. 2007 Nov;107(2):173-6. Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop. Bast RC, Thigpen JT, ArbuckSG, Basen-Engquist K, Burke LB, Freedman R, Horning SJ, Ozols R, Rustin GJ, Spriggs D, Wenzel LB, Pazdur R. With permission from Elsevier.