Lapatinib

Glaxo Smith Kline has had successful overseas clinical trials of lapatinib as a first-line therapy for HER2 B/C, as well as other trials for use in HER2 B/C that has progressed after standard chemotherapy and Herceptin. I don't understand why they are delaying seeking FDA approval until late 2006 or 2007. I know we all get frustrated as we cling to hope of the next miracle treatment, but this is really discouraging. It's hard to sit around reading the promising study abstracts, while your loved one gets sicker and sicker.

Unfortunately, an item that Rich posted on the "articles of interest" board contained this:

"Hauber suggests that some products toward the end of the GSK pipeline, including the breast and lung cancer drug Lapatinib, could be prone to setbacks because they were rushed through earlier research stages. She wrote that "significant miscalculations were made" in the development of Lapatinib and that "marketing considerations appear to have overruled preclinical insights, and Phase III trials were begun before data from (failed) pivotal Phase II studies became available." Her conclusion: "Ongoing Phase III studies have high risk of failure in our view, suggesting that the current submission target (2006/07) is too ambitious. Lapatinib may not reach the market in this decade." That would be a large blow to the GSK pipeline and to the company in general. "

So, it looks like there are reasons why lapatinib isn't on the fast track.

Would it be possible to find a clinical trial? Just recently I read two medical journal articles about phase I clinical trials (the riskiest kind) and they both pointed out that this type of trial has become either safer and as effective or safer and much more effectie than trials in the past. One of them pointed out that 40% of patients who participated in phase I trials benefited. The trials where FDA-approved drugs are transferred to use for breast cancer are the least risky ones in terms of cost/benefit, followed by the trials where non-toxic agents were being studied and while the trials with completely new chemo regimes were the riskiest.

Best of luck,

Christine MH

[michele u]

Dear Guest,
I would love to read any information on Lapatinib for early breast cancer Her2 pos. I'm wanting to take this as soon as possible to prevent a recurrence, like hormone pos women get Tamoxifen. i'm hoping this all transpires with this med, since it is oral. If you have any links, please let me know

I just enrolled in a Phase III clinical study by GSK for Lapatinib. It appears to be designed for those who failed herceptin. One arm gets xeloda, and the other xeloda with lapatinib.

Shell