A	B	C	D	E	F
1	Main
2		Brand Name	Gemzar
3		Generic Name	Gemcitabine
4		Indication
5		Mechanism
6		Administration
7		IP	Potential at-risk launch by TEVA in 2008? 11/2010 PDUFA date.
8		Economics
9		Clinical Studies
10			Phase III Maintenance vs BSC in 1L NSCLC - ASCO #8011 2008
11			n=663 50% adeno, 27% squamous. All had induction chemo, 49% had CR/PR.
12			4.3m PFS vs 2.6m PFS. 13mo OS vs 10.2m OS.
13
14
15
16			Pancreatic Cancer, Gemcitabine vs. 5-FU, n=126
17
18				Gemzar	5-FU	p-value
19			Patients	63	63
20			Stage IV	0.714	0.762
21			Clinical Benefit Response	0.222	0.048	0.004
22
23			Median Overall Survival	5.7 months	4.2 months	0.0009
24			6-month probability	0.46	0.29
25			9-month probability	0.24	0.05
26			1-year probability	0.18	0.02
27			95% CI of the median	4.7 to 6.9	3.1 to 5.1
28
29			Median TTP	2.1 months	.9 months	0.0013
30			95% CI	1.9 to 3.4	.9 to 1.1