GSK withdraws tykerb+herceptin application from FDA

[Lani]

GSK pulls U.S. bid to use Tykerb with Herceptin


LONDON | Thu Jul 12, 2012 11:03am EDT

(Reuters) - British group GlaxoSmithKline has pulled a U.S. application seeking approval to use its breast cancer drug Tykerb in combination with Roche's rival product Herception for certain patients with advanced disease.

A green light for combined administration of the two drugs would expand the use of GSK's Tykerb - sales of which have been limited - by offering a new treatment option for very sick women with metastatic cancer.

"Our discussions with FDA (U.S. Food and Drug Administration) highlighted questions that could not be addressed with the data currently available," said Rafael Amado, GSK's head of oncology R&D.

As a result, Britain's biggest drugmaker said it had decided to withdraw its application and wait for results from further ongoing studies testing the drug combination.

An FDA advisory committee had been scheduled to consider on July 24 the use of Tykerb with Herceptin for patients with metastatic breast cancer whose tumors over-express the HER2 protein and who have had prior Herceptin treatment.

Regulatory reviews of the drug combination are continuing in Europe and other countries despite the U.S. move.

(Reporting by Ben Hirschler; Editing by Dan Lalor)

[Rolepaul]

This is frustrating. I understand their reasoning, but I think they had some patients that were very advanced in their disease that might have affected outcome analysis. The decision would still would allow patients to have this combination, but it would be with their doctor agreeing to it and their insurance company agreeeing to cover it. I am waiting to see their data for the clinical trial to understand the decision better. Please do not give up for those that are looking at this treatment.

[MJsHusband]

Well, this news really stinks!

[Ceesun]

Wow...I have been on this combo for 2 and 1/2 years now. Ceesun

[KDR]

Ceesun,
I was on it, too--always wished I'd had the same outcome as you did, that is to be maintained on it. Unfortunately, our strategy didn't work for me, disappointing because it's quite easy.

It is frustrating to think we can't just get what we need as we need it.

Take care all,
Karen

[qpdawlsmom]

That is confusing! I am currently taking tykerb with herceptin and have been since last October. Prior to that I had finished a year of herceptin alone. I am HER2NEU, so I am quite confused by the post. My doctor has not mentioned anything. Wonder how this will affect my current treatment? Guess I have some more questions for the onc tomorrow.

[karen z]

Thanks for this important post.
karen z

[yanyan]

The t/h combo was due for FDA review but a few major insurance companies already approved these 2 combined to treat advanced and metastatic her2 breast can cancer although it is not on the preferred list. As long As your insurance approves the treatment it will be covered.

[Nancy L]

I was on the t/h combo from 2/2009 to 6/2012 when it was confirmed that I have a 2 1/2 cm tumor in my right supraclavical area. Based on the size or the tumor and how I have been feeling, I think T/H stopped working over a year ago but they just couldn't confirm anything on scans. I am currently going trough radiation therapy and looking for a drug trial of TDM-1. I had hoped to get Perjeta + Herceptin which is what Dr. Slamon ordered for me but it looks like Genentech is not going to give it to me. And it can't be about the cost of producing a dose of Perjeta---the research costs have been incurred over many previous years and are sunk costs unless they can get more women approved for this protocol. Dr. Slamon told me he was working with Perjeta in his lab at the same time as they were studying Herceptin. They went with Herceptin because it was slightly better. But he said the two drugs given together work better than either of them work as a single agent. And even he doesn't have the pull and respect which would allow him to prescribe what he thinks is best for my individual situation.

My feeling is that any woman who is Stage IV should be able to sign a liability release and get access to any of these combos that have shown success, even if it is only been for one woman. The researchers could learn a lot quickly if they allowed more woman in the tent than blocking the door. It almost makes you believe the FDA really isn't interested in personalized medicine and want to continue approving the "one size fits all" treatment programs for metatasis which we all know do not work. If a drug is basically safe to administer to humans, I think they should be out of the business of deciding if it works for a large group of women. The FDA should strickly be about determining safety and let the women with the disease demononstrate if the drugs work or not. Even on the safety issue I guestion the FDA objective---which is more cruel???? 1) letting a woman die of the disease 2) letting a woman die from taking a drug that might stop the disease and learning something for others. The time wasted fighting for HER2 drugs is cruel to the patients and their families. I was so sure I could have another targeted therapy to try when T/H stopped working but now I am not so sure.

[marvass]

Crazy world, what is going on.