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Medical Forum / Diseases and Disorders / Breast Cancer / March 2007

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YES!!!!!  Lapatanib's been approved!

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Eva - 14 Mar 2007 03:17 GMT
(I hope it doesn't turn out to cause Alzheimer's or something.....but I have
great hopes that this stuff can save my life.  And it's not an IV, it's a
*pill*!!!!!!)
Eva
Mari@net.ac - 14 Mar 2007 11:19 GMT
>(I hope it doesn't turn out to cause Alzheimer's or something.....but I have
>great hopes that this stuff can save my life.  And it's not an IV, it's a
>*pill*!!!!!!)
>Eva

I wasn't familiar with this so I did a search:

Positive results halt trial of new Herceptin rival
Wednesday, May 03, 2006

Better than expected results for a new drug for advanced breast cancer
have led to trials being halted, in order to allow more women to benefit
from the treatment.

GlaxoSmithKline's Tycerb (lapatinib) was being used to treat advanced
breast cancer in women in combination with capacitabine (Roche's Xeloda)
in phase III trials comparing it with capacitabine alone.

Results were so positive for the women taking the new combination that
an independent monitoring committee said enrolment in the trial should
end, with all women on the trial given the choice of receiving the dual
therapy.

Like the much-publicised Herceptin, GSK's new drug targets the sub-group
of women with breast cancer who have an aggressive form of the disease,
known as HER2 or ErbB2 positive.

Herceptin works by blocking the effect of the ErbB2 gene, which is
associated with cancer that grows faster and spreads to other organs
more quickly.

By blocking the stimulation of these genes, Herceptin can slow or halt
the progress of the disease and ultimately save lives.

But Tycerb could have significant benefits over Herceptin. Firstly, the
new drug not only targets the ErbB2 receptor but also the similar ErbB1
receptor, which is also associated with accelerated cancer growth. By
blocking the stimulation of both genes, GSK hopes its drug could be even
more effective than Herceptin.

Secondly, lapatanib is a small molecule drug taken as a pill, making it
easier to manufacture and more convenient for patients compared to
Herceptin, which must be administered via intravenous infusion.

Paulo Paoletti, head of GSK's oncology development centre commented: "We
are extremely encouraged by these data which suggest that Tycerb may
offer significant benefit as an oral medication in combination with
chemotherapy for patients with advanced or metastatic ErbB2 positive
breast cancer, and whose disease has progressed on previous treatment
regimens, including Herceptin.

"On the basis of this and other data we now plan to file in the US and
Europe during the second half of 2006."

By the time women are first diagnosed with breast cancer, between 10-20%
are already in the advanced stages of the disease, with either locally
advanced tumours or a metastatic tumour spreading the cancer to other
organs.

Currently the median survival time for these women is just two years,
and GSK hopes Tycerb will prove to be an advance in treating these
women.

The company has not released extensive details of the trial results, but
has confirmed that the drug significantly exceeded its primary endpoint
of a 50% increase in the time to disease progression (TTP).

GSK says it is using advanced technologies, including pharmacogenetics
to determine which patients will respond the most to the new drug.

http://www.pharmafocus.com/cda/focusH/1,2109,21-0-0-MAY_2006-focus_news_detail-0
-437843,00.html

allan - 14 Mar 2007 12:09 GMT
> (I hope it doesn't turn out to cause Alzheimer's or something.....but I have
> great hopes that this stuff can save my life.  And it's not an IV, it's a
> *pill*!!!!!!)

Can I get a source, Eva?  Deborah and I have been waiting for
Lapatinib to be approved and need something to cite so we can go to
our insurance company.

thanks -
J - 14 Mar 2007 12:32 GMT
> > (I hope it doesn't turn out to cause Alzheimer's or something.....but I have
> > great hopes that this stuff can save my life.  And it's not an IV, it's a
[quoted text clipped - 5 lines]
>
> thanks -

It was tested with capecitabine (Xeloda) vs Xeloda alone and seems to target brain
mets
there are less toxicifying ways, to the whole body, to address brain mets - RT
J
<http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_060606/page2>
The phase III study randomly assigned 160 women to receive lapatinib plus
capecitabine and 161 women to receive capecitabine alone. All of the women had
advanced or metastatic breast cancer that had recurred or progressed following
prior therapy with an anthracycline drug, a taxane, and trastuzumab.

"The inhibition of lapatinib's second target, EGFR, may not benefit women with
breast cancer but could make the drug useful against other cancers, said Dr. Julie
Gralow of the University of Washington, who commented on the study at ASCO."
<quote>

http://www.newsday.com/news/health/ny-hscanc145129875mar14,0,3565299.story?coll=
ny-health-print


FDA OKs drug for aggressive breast cancer
March 14, 2007
Evidence suggests that Tykerb can breach the blood-brain barrier, the protective
sheath that keeps most substances out of the brain.

Thus the new drug is more likely to reach cancers that have metastasized to the
brain.<end quote>

Seems to me they should have tested vs Herceptin?

http://www.chron.com/disp/story.mpl/nation/4583937.html
Funding seems to affect breast cancer drug trial results
Peppercorn's team looked at 140 breast cancer studies published in 1993, 1998 or
2003 in leading medical journals. Among all 140 published studies analyzed,
researchers found that 78 percent of industry-sponsored studies reported favorable
results, while just 66 percent of non-industry studies were positive.

Peppercorn said there are many possible explanations for the discrepancy. For one,
he said, drug companies may be less inclined to publish when studies are negative.
Or it could be that pharmaceutical companies are "flat out better" at identifying
medicines most likely to perform well in clinical trials, Peppercorn said.

A new national clinical trials registry, administered by the federal government,
will track results from all registered trials, published or not.

That data will eventually make it easier to know whether industry-backed trials
actually produce better results, or whether drug companies are burying their bad
results by not publishing,

Less good research?
"We know how to do clinical trials," said Alan Goldhammer, deputy vice president
of regulatory affairs for PhARMA. "A lot of drugs that are not going to be
successful are never brought into the clinic. Of course we're going to be more
likely to publish favorable results."

Jerome Reichman, a professor at Duke University Law School and critic of the
pharmaceutical industry's growing role in clinical trials, said he doesn't accept
the industry explanation. He notes that pharmaceutical companies often justify
high drug prices by saying they have to cover the costs of testing drugs that
flop.

Reichman said having the drug companies behind clinical trials means there will be
less good research comparing how well new products do against existing drugs.

"They will never ask the question, 'Is there another drug that will do just as
good or better at a cheaper price?' — they have no incentive," said Reichman, who
co-wrote a recent paper that argues for public funding and oversight of clinical
trials. It was published in the January issue of the journal Economist's
Voice<quote>
allan - 14 Mar 2007 12:52 GMT
Thank you, J. - I've been watching this one closely.

Calling my insurance company to get special dispensation now.

Wish me luck -
Eva - 14 Mar 2007 12:32 GMT
> > (I hope it doesn't turn out to cause Alzheimer's or something.....but I have
> > great hopes that this stuff can save my life.  And it's not an IV, it's a
[quoted text clipped - 3 lines]
> Lapatinib to be approved and need something to cite so we can go to
> our insurance company.
----------------
It's all over the place, but here are two to start with:

http://www.cbsnews.com/stories/2007/03/13/health/main2564600.shtml

http://www.nytimes.com/2007/03/14/business/14drugs.html?_r=1&oref=slogin

Eva
allan - 14 Mar 2007 13:09 GMT
> It's all over the place, but here are two to start with:
>
> http://www.cbsnews.com/stories/2007/03/13/health/main2564600.shtml
>
> http://www.nytimes.com/2007/03/14/business/14drugs.html?_r=1&oref=slogin

Thank you, Eva.  I have a call in to Dr, Smiley now - why doesn't it
surprise me that this stuff costs $3000 a month?

cheers -
allan - 14 Mar 2007 13:42 GMT
Okay, I've spoken to Dr. Smiley (he agrees, since the last CA 15-3
only dropped a tenth of a point on Gemzar + Herceptin and we both
expect her next set of tests to show her markers have risen a little),
have a call in to my insurance company and have spoken to
GlaxoSmithKline about putting a boot in Blue Cross/Blue Shield's
backside.

We'll see what happens  ;-)
Mari@net.ac - 14 Mar 2007 14:02 GMT
Dr Sanjay Gupta just covered this on CNN.  They show the same segments
several times a day so it will be on again. Fabulous news.

Marilyn
Mary Fisher - 14 Mar 2007 14:55 GMT
> Okay, I've spoken to Dr. Smiley (he agrees, since the last CA 15-3
> only dropped a tenth of a point on Gemzar + Herceptin and we both
[quoted text clipped - 4 lines]
>
> We'll see what happens  ;-)

I'm kicking as hard as I can on your behalf!

Mary
Bea Oo - 19 Mar 2007 23:35 GMT
I am very happy for those of you who find this new drug to be the answer
to their prayers.  However, this frightens me as to what is going on.
Why are the Oncologists only able to give these drugs to people who may
be clinging on for help?  Why isn't drugs like Herceptin and now this
one given to people like myself who were diagnosed with ER Positive and
HER-2 neu positive bc NOW?? Why do they wait until something aggressive
happens and then are able to give them.

I read,  over our local tv news which did a segment tonight on Tycerb,
that it can only be given to women who have already taken Herceptin and
have aggressive bc.  Does this mean all ER Positive/HER-2 neu Positive
bc is not aggressive??  Why risk the lives of people like myself just to
see "what will happen" and then give us the drug?  What if it is too
late then?  I am very disturbed about what they are doing about who can
get the drug.  I am sorry to ask all my questions here but this is the
only place I am able to get any logical answers.  So if you know why
they aren't giving it to all of us with these type bc, please let me
know.  

Thanks for any information or advice.

Bea

'NO FORWARDS OR SPAM, PLEASE"
Eva - 20 Mar 2007 06:26 GMT
> I am very happy for those of you who find this new drug to be the answer
> to their prayers.  However, this frightens me as to what is going on.
[quoted text clipped - 16 lines]
>
> Thanks for any information or advice.
-----------------
I agree with you, but I think doctors will start prescribing it "off-label"
to Stage III patients and those not taking Xeloda.  It's just a matter of
time.  They initially only approved Herceptin for Stage IV patients but I
was Stage III and I was given it.  (This is the one good thing about the
profit-driven US health care system.  If I lived in Canada or the UK I
probably would not have gotten Herceptin and I wouldn't be talking to you
now.)

Eva
Tim Jackson - 20 Mar 2007 09:13 GMT
> I am very happy for those of you who find this new drug to be the answer
> to their prayers.  However, this frightens me as to what is going on.
[quoted text clipped - 20 lines]
>
> 'NO FORWARDS OR SPAM, PLEASE"

Firstly it is a new drug and knowledge of the side effects is limited,
so the tendency is at this stage only to give it to patients who have
little to lose.  Of those patients who's metastatic cancer failed to
respond to chemotherapy and Herceptin, about half responded to
lapatinib.  It is not known how effective it would be for other parts of
the population.

Secondly these drugs are very expensive, and for health insurers to pay
for them for a wide range of patients inevitably means that they have
less to pay for other treatments for other patients, or else the overall
cost of insurance goes up.  In the UK some hospitals are having to close
beds and cut operation lists in other areas in order to fund the NHS
requirement to give Herceptin to cancer patients, for example.

Of course that does not affect those who would pay for their drugs
privately, but relatively few can afford that.

There is a worldwide phase III clinical trial by GSK currently
recruiting called TEACH that is investigating its possible use as an
adjuvant therapy.
http://clinicaltrials.gov/ct/show/NCT00374322

Tim Jackson
allan - 20 Mar 2007 13:04 GMT
> I am very happy for those of you who find this new drug to be the answer
> to their prayers.  However, this frightens me as to what is going on.
[quoted text clipped - 3 lines]
> HER-2 neu positive bc NOW?? Why do they wait until something aggressive
> happens and then are able to give them.

Because it really doesn't make any difference, Bea - if it's effective
in early stages it'll be effective in later stages.  If it works, it
works - and at almost $3000 a month Tykerb probably isn't something to
give to the masses.

hugs -

allan
 
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