MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Genentech and FDA notified healthcare professionals of updated
cardiotoxicity information related to the use of Herceptin (trastuzumab),
obtained from the National Surgical Adjuvant Breast and Bowel Project
(NSABP) study (B-31), a randomized, Phase III trial that was conducted in
2043 women with operable, HER2 overexpressing breast cancer (IHC 3+ or
FISH+). This study demonstrated a significant increase in cardiotoxicity in
patients who were randomized to the Herceptin-containing arm as compared to
patients who received chemotherapy alone.

Preliminary analysis of safety data from Study NSABP B-31 and the North
Central Cancer Treatment Group (NCCTG) study (N9831) revealed a
statistically significant increase in the 3-year cumulative incidence of
New
York Heart Association Class III and IV congestive heart failure and
cardiac
death observed in patients who received the Herceptin-containing regimen
(4.1%) compared with control (0.8%). There were no cardiac deaths observed
in patients who received the Herceptin-containing regimen and one cardiac
death was observed in the control arm. Final analysis of the cardiac safety
data collected in Studies NSABP B-31 and NCCTG N9831 is ongoing.

Read the completed MedWatch 2005 Safety Summary including the link to the
Dear Healthcare Provider Letter at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Herceptin

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