Neupogen

Clinical Pharmacology

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Clinical Pharmacology

Neupogen

None of the conditioning regimens used in the ABMT studies included radiation therapy.

While these studies were not designed to compare survival‚ this information was collected and evaluated. The overall survival and disease progression of patients receiving NEUPOGEN® in these studies were similar to those observed in the respective control groups and to historical data.

Peripheral Blood Progenitor Cell Collection and Therapy in Cancer Patients

All patients in the Amgen-sponsored trials received a similar mobilization/collection regimen: NEUPOGEN® was administered for 6 to 7 days‚ with an apheresis procedure on days 5‚ 6, and 7 (except for a limited number of patients receiving apheresis on days 4‚ 6, and 8). In a non-Amgen-sponsored study‚ patients underwent mobilization to a target number of mononuclear cells (MNC)‚ with apheresis starting on day 5. There are no data on the mobilization of peripheral blood progenitor cells (PBPC) after days 4 to 5 that are not confounded by leukapheresis.

Mobilization: Mobilization of PBPC was studied in 50 heavily pretreated patients (median number of prior cycles = 9.5) with NHL‚ HD, or ALL (Amgen study 1). CFU-GM was used as the marker for engraftable PBPC. The median CFU-GM level on each day of mobilization was determined from the data available (CFU-GM assays were not obtained on all patients on each day of mobilization). These data are presented below.

The data from Amgen study 1 were supported by data from Amgen study 2 in which 22 pretreated breast cancer patients (median number of prior cycles = 3) were studied. Both the CFU-GM and CD34⁺ cells reached a maximum on day 5 at > 10-fold over baseline and then remained elevated with leukapheresis.

Progenitor Cell Levels in Peripheral Blood by Mobilization Day
	Overall Study 1 CFU-GM/mL		Study 2 CFU-GM/mL		Study 2 CD34+ (x 104/mL)
	No. Samples	Median (25% – 75%)	No. Samples	Median (25% – 75%)	No. Sample	Median s (25% – 75%)
Day 1	11	18 (13 – 62)	20	42 (15 – 151)	20	0.13 (0.02 – 0.66)
Day 2	7	22 (3 – 61)	n/a	n/a	n/a	n/a
Day 3	10	138 (39 – 364)	n/a	n/a	n/a	n/a
Day 4	18	365 (158 – 864)	18	576 (108 – 1819)	17	2.11 (0.58 – 3.93)
Day 5	36	781 (391 – 1608)	21	960 (72 – 1677)	22	3.16 (1.08 – 6.11)
Day 6	46	505 (199 – 1397)	22	756 (70 – 3486)	22	2.67 (1.09 – 4.40)
Day 7	37	333 (111 – 938)	22	597 (118 – 2009)	21	2.64 (0.78 – 4.22)
Day 8	15	383 (94 – 815)	12	51 (10 – 746)	12	1.61 (0.38 – 4.31)
n/a = not available