Genetech Wins FDA Approval For Herceptin For Breast Cancer

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By Douglas A. McIntyre Published
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Genentech (DNA) announced that the FDA approved its Herceptin cancer treatment for an expanded use for adjuvant treatment of HER2-positive node-positive breast cancer. The studies showed a 52% reduction in the recurrence of breast cancer of some 3,500 patients in two Phase III studies and is the only targeted biologic therapy approved for use in adjuvant and metastatic HER2-positive breast cancer.Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment – surgery with or without radiation therapy – with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease. After three-and-a-half years in the study, 87 percent of women treated with Herceptin plus chemotherapy were disease free, compared to 71 percent of women treated with chemotherapy alone. A survival analysis conducted after patients had been followed for a median of 24 months showed a 33 percent reduction in the risk of death (based on a hazard ratio of 0.67), which is equivalent to a 49 percent improvement in overall survival.DNA shares closed up 0.35% at $80.72 in regulartrading, but shares are up 0.9% at $81.45 in after-hours trading. DNA has a 52-week trading range of $75.58 to $100.20.Jon C. Ogg

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About the Author Douglas A. McIntyre →

Douglas A. McIntyre is the co-founder, chief executive officer and editor in chief of 24/7 Wall St. and 24/7 Tempo. He has held these jobs since 2006.

McIntyre has written thousands of articles for 24/7 Wall St. He is an expert on corporate finance, the automotive industry, media companies and international finance. He has edited articles on national demographics, sports, personal income and travel.

His work has been quoted or mentioned in The New York Times, The Wall Street Journal, Los Angeles Times, The Washington Post, NBC News, Time, The New Yorker, HuffPost USA Today, Business Insider, Yahoo, AOL, MarketWatch, The Atlantic, Bloomberg, New York Post, Chicago Tribune, Forbes, The Guardian and many other major publications. McIntyre has been a guest on CNBC, the BBC and television and radio stations across the country.

A magna cum laude graduate of Harvard College, McIntyre also was president of The Harvard Advocate. Founded in 1866, the Advocate is the oldest college publication in the United States.

TheStreet.com, Comps.com and Edgar Online are some of the public companies for which McIntyre served on the board of directors. He was a Vicinity Corporation board member when the company was sold to Microsoft in 2002. He served on the audit committees of some of these companies.

McIntyre has been the CEO of FutureSource, a provider of trading terminals and news to commodities and futures traders. He was president of Switchboard, the online phone directory company. He served as chairman and CEO of On2 Technologies, the video compression company that provided video compression software for Adobe’s Flash. Google bought On2 in 2009.

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