Lapatinib approval?

[Sherryg683]

I've heard the talk about Lapatinib. Does anyone know when it is likely to be approved for use by everyone. I know the trials are underway now..sherryg683

Sherry,
My understanding is that currently only the people that " qualify" for Laptinib are those that have already been diagnosed with brain mets--
Anyone-- correct me if I'm wrong.
Carol

[Joe]

There are other clinical trials other than brain mets with Lapatinib, here is a list of current studies:

http://www.clinicaltrials.gov/ct/sea...inib%2C+breast

GSK may be presenting some preliminary data about Lapatinib at ASCO in June and
may apply for FDA approval in early 2007.

Regards
Joe

[Joe]

From the GSK 2005 Annual Report:

"GSK expects to file Tykerb, an innovative once-daily oral treatment for breast cancer, in late 2006/H1 2007. GSK continues to investigate the use of Tykerb to treat other cancers. Data received in the quarter showed a survival benefit in renal cancer patients who over-express EGFR. Current treatment options for renal cancer are limited and these data, along with clinical studies on inflammatory breast cancer and brain metastases, have been submitted for presentation to ASCO in June 2006."

Tykerb is another name for Lapatinib.


Regards
Joe

[michele u]

I wonder if Tykerb (Lapatinib) gets approved, if we can prove that we are positive EGFR that we can get it off label, being stage 3? I know my onc. tried to ask about it for me and they told him no.

My understanding of "off label" prescription is that once a drug is approved for any indication, a doctor has the authority to prescribe it for whatever they want. That's what makes it off label. Correct?

[Sandy H]

Rich, I believe you are correct. My oncologist said as soon as it is released he will use it on me but doesn't want to use it with the chemo they are using in the trials. I hope it gets released soon not only for myself but for others. Sandy