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Scott,
Lapatinib has been approved for stage 3 trials. My understanding is that part of the hold-up has been due to zeroing on the parameters which wll result in the correct selection of patients; because they don't want to see the drug go down due to lousy project planning. For example, there were enough people trying to torpedo herceptin during the development stages that if the patients weren't properly selected herceptin would be history by now; never approved by the FDA. A better example of this is Iressa, another hopeful small molecule tyrosine kinase inhibitor, which was so successful in other cancer trials that they got sloppy in the BC trials and .....try to find it now. Targetted therapies are exactly what the name implies...VERY targetted; which means they work on a very select and TARGETTED group of patients.
Expect more on this drug, now called TYKERB, at ASCO next year.
Regards,
Al
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Primary care-giver to and advocate for Linda, who passed away April 27, 2006.
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