Replies to post #87433 on Biotech Values

[p3analyze]

IMGN - I would expect if Roche had truly desired a BLA they would have requested a meeting with FDA a long time ago, because I assume Roche has known about the response rate from this single-arm study for quite a while. Yes mature PFS median would help, but it doesn't mean much to the regulators imo.

[p3analyze]

Roche Slides Potential Oncology Submissions 2010

http://www.roche.com/investors/ir_agenda/sabcs2009.htm

Key Oncology Milestones in 2010
• Avastin Phase III Data
– CALGB 90401 for 1L hormone-refractory
prostate cancer
– AVANT adjuvant colon cancer
– AVAGAST for 1L advanced gastric cancer
– GOG-218 and ICON-7 for 1L metastatic ovarian
cancer
– OCEANS for relapsed platinum-sensitive ovarian
cancer
• Other Potential Oncology Data Results in 2010
– Xeloda Phase III NO17629 in adjuvant BC
– T-DM1 Phase II in 1L HER2+ metastatic breast
cancer
– Pertuzumab Phase II in HER2+ neoadjuvant
breast cancer


• Potential Oncology Regulatory Submissions
– Avastin
• RIBBON-2 in 2L metastatic breast cancer
• AVAGAST metastatic gastric cancer
• GOG218/ICON-7 in 1L ovarian cancer
• AVANT adjuvant colon cancer
– ToGA: Herceptin in HER2+ gastric cancer in the US
– PRIMA: MabThera/Rituxan in indolent NHL
maintenance (1L)
– ATLAS: Tarceva + Avastin in NSCLC maintenance
(1L)
– XELOXA: Xeloda in adjuvant colon
– AVANT: Xeloda + oxaliplatin + Avastin in adjuvant
colon cancer

• Potential Oncology Approvals
– SATURN: Tarceva in 1L maintenance therapy for
advanced NSCLC
– ToGA: Herceptin in HER2+ gastric cancer in the EU
– Rituxan 1L/relapsed CLL (US)
– Avastin RIBBON-1/AVADO (US), RIBBON-1 (EU)