Lapatinib

Esther · 03-02-2007, 04:58 PM

I had a consult with Dr. Pegram at UCLA yesterday, to discuss Lapatinib as a possible treatment for me.

He indicated that he expected it to be FDA approved on March 13th, and that it would be available shortly after that locally. He recommended that I add the Lapatinib to Herceptin.

In his opinion, the major benefit with brain mets, was in preventing new ones from developing. The success rate in reducing the size of existing lesions was in the single digits.

It may be a promising new treatment era in the near future. Herceptin alone has kept me fairly steady in the liver and bone mets for 2 years now, perhaps the time is coming when Lapatinib/Herceptin will do the same for our brain mets issues as well.

As always, Dr. Pegram was reassuring and informative and I value being able to consult with him.

Mary Anne in TX · 03-02-2007, 06:20 PM

who will qualify for the lapitinib when it is approved?

Lolly · 03-02-2007, 06:22 PM

Esther, thank you very much for sharing your information with us from one of the "guru's" of Her2+ therapy. Very encouraging to hear his thoughts on the value of adding Lapatinib to Herceptin. My onc will be quite interested if I may share your info with him?

<3 Lolly

Lolly · 03-02-2007, 07:02 PM

Mary Anne, here's a link to a post from Lani in the Articles of Interest section, regarding approval of Lapatinib (Tykerb), and note, please read Becky's response further down as she is quite correct and I've edited my response accordingly:

http://www.her2support.org/vbulletin...ight=lapatinib

Plus an excerpt below from an article I found about the approved uses for Lapatinib. Once a drug is approved by the FDA, it can then be prescribed by one's physician (if the use doesn't exactly fit within the parameters of the FDA approval it's called "off-label" use and as such is not always covered by one's insurance. Case in point would be the use of Navelbine in breast cancer; it was first approved for use in Non Small Cell Lung Cancer, but crossed over into use for breast cancer before approval from the FDA for use in breast cancer).
Once Lapatinib is approved some physicians will be prescribing it to patients with Stage IV disease who are or have been on Herceptin, who have had a relapse.

Lapatinib Plus Capecitabine for HER2-Positive Advanced Breast Cancer<O

</O

Currently, lapatinib is available to patients through an expanded access program while undergoing US Food and Drug Administration (FDA) review.Approval is anticipated in the relapsed setting for use with capecitabine. With lapatinib's success come many questions. Should it be used in earlier treatment settings? Can it be combined with other chemotherapies or trastuzumab? What is capecitabine's impact in this combination regimen? Will lapatinib prevent or treat brain metastases? Many of these questions should be answered by ongoing and planned studies.<O</O

Sandy H · 03-02-2007, 08:04 PM

Thanks Esther that is good news. Have been looking to hear some info on this as it is getting near the middle of the month. hugs, Sandy

Esther · 03-02-2007, 09:12 PM

Mary Anne, once Lapatinib is approved, your onc would be able to prescribe it to anyone who is her2+++.

This may just be the most exciting thing I've heard in the last few years. It may mean a much lower rate of brain mets for us her2+++ gals who are living longer with the help of herceptin.

Dr. Pegram feels it dovetails nicely with the benefits Herceptin provides.

Mary Anne in TX · 03-03-2007, 05:55 AM

Esther and Lolly, thanks so much for the info. I have really wondered if I ought to talk to Dr. K about putting me on Tykerb when I finish Herceptin in June to help avoid the spread of tumors to other areas. I'm so much NOT a detail person that I didn't really understand all the benefits of some of the drugs. I'll read and figure this out. Love and sunshine

to you both! ma

Becky · 03-03-2007, 07:45 AM

I believe that once Tykerb is approved, an onc can and will prescribe it to anyone who is progressing that is STAGE 4. Think about 1998 when Herceptin was approved for Stage 4. Oncs used it for Stage 4. Very, very, very few of us who were not 4s got adjuvant Herceptin unless they were on the trial. An adjuvant trial (2 of them) are looming (waiting for Tykerb to be FDA approved for metastatic disease which is protocol. Then their trials have to be approved).

There is no data that Tykerb works in less than Stage 4 but it probably will show results in the adjuvant setting like Herceptin has. But anyone who is not stage 4 will not be able to get it and insurance will not pay for it (there will be some rare exceptions I am sure). Even aromotase inhibitors that were okayed for early stage in October, 2004 were impossible to get unless Stage 4 until then and they were on the market for stage 4 for years.

I just want to make sure that those on the board realize that Tykerb is not universally available just because you are Her2+ because it is not and won't be unless you are Stage 4.

supermehra · 03-03-2007, 09:05 AM

Esther,

Thanks for sharing this info. I am curious on what your onco said (if anything at all) for people who already have brain met(s)?

Thanks,
Sachin

Christine · 03-03-2007, 09:21 AM

I am scheduled to attend a GSK teleconference on the 16th. Hopefully I'll come back with some answers, but GSK can only comment on what the FDA has approved.

Hugs
Christine

Mary Anne in TX · 03-03-2007, 10:03 AM

Thank you Christine and Becky!
I'm not quite sure why it matters so much to know, but it does. I seem to let go of those things I can't control, and it takes the stess off Big Time. Thanks again. I'll wait to hear the news.

ma

Val Pfeiffer · 03-03-2007, 08:03 PM

So Becky....what do you mean about it taking years before docs will prescribe drugs "off-label"? Is there a set number of years? I received neo-adjuvant Herceptin as a stage 2 or 3 (they didn't know my stage until after surgery) in 2004, which was before it was approved for anything other than stage 4. I thought that once something is approved by the FDA that docs had latitude to use it in other ways. I realize that each drug is different. But I'm thinking this: I have a pretty good track record of gaining approval from my insurance company--their philosphy is that if they have approved the doc as one of their practitioners and that doc is recommending a course of action, they will approve it. So am I being naive for thinking that if I get my oncologist to prescribe Tykerb that I will be able to get it? Or is there some rule about new drugs being used off-label?

Also--Was there a certain time frame after Hercetin was approved whereby it could officially be used off-label? I thought off-label was when drugs were being used in ways that were not FDA approved. I'm so confused!