Amgen 2007 Annual Report Download - page 24

Certain ESA Postmarketing Commitments
Following the ODAC meeting in May 2004, we proposed a pharmacovigilance program comprised of five
ongoing studies for Aranesp®, which sought to explore the use of ESAs in settings different from those outlined
in the FDA approved label. These studies were subsequently designated by the FDA as PMCs. One of the five
studies, the 20010145 (“145”) study, was an Amgen sponsored study, with the other four studies being
investigator-sponsored studies. The following table summarizes the five studies:
Sponsor Study Tumor Type
Target Hb
(g/dL) Study Results
Amgen 20010145 Small cell lung 13 At median follow-up of 2
1
⁄ 2 years,
ESA and placebo group had similar
PFS and overall survival; PFS
based on blinded central review
similar between ESA and placebo
DAHANCA DAHANCA-10 Head and neck 14-15.5 5-year locoregional control poorer
in ESA group; No significant
difference in overall survival
AGO PREPARE Neoadjuvant breast 12.5-13 No significant difference in
pathologic complete remission
between groups; Decreased 3-year
relapse-free and overall survival
GELA(1) LNH-03-6B NHL(2) 13-15 initially,
amended to
13-14
At 1 year, ESA and control groups
had similar overall survival and
event-free survival(3)
WSG(4) ARA-03 Adjuvant breast 13-14 Interim results published(5)
(1) Groupe d’Etudes des Lymphomes de l’Adulte (“GELA”)
(2) Non-Hodgkin’s Lymphoma (“NHL”)
(3) The final study report is expected in 2010. Late in 2007, an independent Data Safety Monitoring Committee
recommended continuation of the study unchanged.
(4) West German Study Group (“WSG”)
(5) Interim results presented by study investigator at the 2007 American Society of Clinical Oncologists
conference indicated a higher incidence of thromboembolic events in the ESA group. The final study report
is expected in 2011.
In addition, J&JPRD and/or its investigators have conducted numerous studies proposed at the 2004 ODAC
meeting including: the EPO-GBR-7 and RTOG-9903 studies in HNC, the EPO-GER-22 and EPO-CAN-20 stud-
ies in NSCLC, the EPO-CAN-17 and EPO-GER-7 studies in breast cancer and the EPO-GER-8/AGO-NOGGO
study in cervical cancer. All of the above studies are closed to enrollment and summary results were submitted to
the FDA. Final study reports for many of these studies are expected in 2008. In addition, J&JPRD’s
EPO-ANE-3010 study in breast cancer is ongoing and is designated as an FDA PMC.
Based on our ongoing discussions with the FDA in response to the May 2007 ODAC meeting, we and
J&JPRD have carefully considered potential new study designs to further evaluate the risk of mortality and tumor
progression with ESAs within the labeled indication of CIA. Based on the safety signals observed with higher Hb
levels, we are working with the FDA to design a large, definitive, well controlled study comparing the safety of
ESAs administered to a maximum Hb target of 12 g/dL per the product labeling versus placebo in three major
tumor types (NSCLC, breast cancer and advanced CRC). We have agreed on the general study design, and plan
to submit a study protocol after obtaining guidance from the ODAC. We and J&JPRD are in discussions with the
FDA as to any additional studies that will be required to address remaining concerns in other disease settings.
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