FDA News Item Regarding Herceptin Clinical Trial

Clinical Trial Information on Herceptin (trastuzumab)

Herceptin is used in patients with metastatic breast cancer whose tumors overexpress the HER2 protein. The FDA approved Herceptin in 1998. Recently, Genentech has sponsored clinical trials involving Herceptin. If you or someone you love was involved in the Herceptin clinical trial and developed congestive heart failure or any other heart problem, contact PritzkerOlsen, P.A. , for a free consultation. You may contact us at 1-888-377-8900 or fill out our online consultation form. Attorney Fred Pritzker has more than 30 years of experience helping people with complex medical and legal cases. He has been named, once again, a Super Lawyer, and has been selected for inclusion in the current edition of The Best Lawyers in America.

FDA news item regarding Herceptin:
August 31, 2005--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.

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