Tykerb (lapatinib) may be effective at shrinking breast cancer tumors in the brain, researchers say. This drug is called a targeted therapy because it can kill cancer cells and leave normal cells alone. Tykerb targets HER2 and EGFR, two proteins that function abnormally in breast cancer cells.

A study was conducted that included 241 breast cancer patients with brain metastasis that continued to progress after radiation treatment and Herceptin therapy.

The study concluded that nearly half of the patients, 46 percent, experienced at least a twenty percent reduction in the size the the brain tumors.

The researchers concluded "Tykerb has promise in the treatment of brain metastasis".

Five new cancer treatments are in the works and could be available for use as early as 2010, thanks to GlaxoSmithKline, PLC, the world's second largest drug company.

The drugs will treat a range of different cancers -- one will be cervical cancer -- and are known as cervarix, pazopanib, promacta, rezonic, and ofatumumab.

"Over the next three years, GSK will make a difference to millions of patients facing cancer," said Glaxo's head of research and development, Moncef Slaoui.

Glaxo's most recent cancer drug is Tykerb, an oral breast cancer treatment launched in March.

Twenty to thirty percent of breast cancers over express a protein referred to as the human epidermal growth factor receptor, better known as HER2 over expression.

Herceptin is an agent that is targeted against the HER2 receptor and helps to slow or stop the spread of cancer cells that over express this protein. Unfortunately, some women that do have the over expression of HER2 on their breast cancer cells do not respond to treatment with Herceptin.

The Journal of the National Cancer Institute has published a report that says among breast cancer patients with HER2 over expressing cancer cells, those whose cells also express a receptor called p95HER2 have a poor anti-cancer response rate with Herceptin.

The study included forty seven women with metastatic breast cancer. All were treated with Herceptin. Nine of these patients also expressed the receptor p95HER2.

The results showed that only 11 percent of the women with the p95HER2 expression showed an anti-cancer response to Herceptin. Of the patients who did not express p95HER2 demonstrated a response of 51 percent. The report also showed that laboratory testing of cancer cells that do express p95HER2 demonstrated anti-cancer activity with a drug called Tykerb.

The researchers concluded that patients with HER2-over expressing breast cancer who also express p95HER2 appear to be more resistant to treatment with Herceptin and "may require alternative or additional anti-HER2–targeting strategies." Patients with HER2-over expressing breast cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating biologic markers that may help predict responses to certain therapies.

Tykerb has been approved by the FDA for use in conjunction with the chemotherapy drug Xeloda. Tykerb is a cancer medication that more precisely targets tumors without killing lots of healthy cells in the process.

Herceptin and Tykerb target a protein called HER-2/neu but work in different ways. Herceptin targets the outside of the HER2 protein and Tykerb works from the inside of the cell. This difference can give advanced breast cancer patients another drug to switch to if Herceptin stops working for them.

Glaxo said that Tykerb will be available in two weeks. The results of a study showed that Tykerb worked so well that the international study was stopped early and all the participants were offered the drug.

The FDA said it was too early to know if women taking Tykerb and Xeloda would live longer than those taking the latter drug alone.

Dr. Steven Galson, FDA drugs chief, said "Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available."

If the experimental breast cancer drug Tykerb continues to prove successful in study participants, it could be headed for FDA approval.

Tykerb, now in international study, showed in early studies to be even more effective and to have fewer side effects than similar breast cancer drug Herceptin. Both drugs are part of a cluster of targeted therapies that attack cancer cells while sparing healthy cells. Designed for use on women whose breast cancer is HER2 positive -- meaning it contains too much of an aggressive protein -- Tykerb may be a wonder drug, with the capability of effectively keeping breast cancer at bay.

Dr. Paul Goss of MA General Hospital says, "We're seeing Tykerb, which is a pill, which is easier to take, has a broader attack and gets inside cells. It's like an electrical circuit that's turned on, and Tykerb can pull the lever, the circuit breaker, and switch it off."

There are sometimes silver linings to the darkest of cancer clouds. I know -- because I have the dark cloud of HER2 positive breast cancer hanging over my head. HER2 positive means the tumor removed from my breast was aggressive. It aggressively over-expressed a protein that accelerates tumor growth. And it led to a poor prognosis -- that might be considered a good one too.

You see, research on the whole HER2 issue is turning up some pretty powerful potions. Like Herceptin -- the drug that miraculously cuts recurrence upwards of 50 percent for positive women like me. I was a lucky recipient of this drug. And the pharmacist who mixed the drug for all 17 of my infusions tells me it's really a good thing I have this HER2 problem -- because the drugs created to attack the problem may just cure me of my disease.

So in an odd turnabout -- from bad luck to good fortune -- I am not so sad my tumor was aggressive. It means there are bonus treatments for me. And if my cancer comes back and Herceptin no longer works, there is another drug called Tykerb. And now the Army is leading its own breast cancer vaccination study. The focus -- HER2.

Early study results from Walter Reed Army Medical Center in Washington, D.C. suggest a 50 percent reduction in disease recurrence for HER2 positive women who receive a vaccination of AE37.

AE37 targets HER2 and boosts the body's immune system so it can battle the protein before it stimulates growth. It's similar to Herceptin, but the activity of AE37 stimulates a patient's own immune system to recognize the cancer target rather than interacting with the target directly.

Should the Food and Drug Administration decide to support this study, it will proceed to Phase 3 testing, which includes a much larger pool of participants.

The combination of breast cancer drugs Tykerb and Xeloda are effective at slowing the progression of metastatic breast cancer after the drug Herceptin fails -- but the drug duo is only effective at extending the lives of patients for a few months, according to the results of a recent international clinical trial.

The trial, led by Charles E. Geyer, M.D., of Allegheny General Hospital, Pittsburgh and published in the December 28 issue of The New England Journal of Medicine, focused on 324 women whose breast cancer had spread to other organs. The women had already been treated with Herceptin for a median of 42-44 weeks -- and then half received Xeloda chemotherapy and half received both Xeloda and Tykerb.

Women who received the drug combination had more than a 50 percent delay in disease progression. Their cancer spread after a median 8.4 months, compared to 4.4 months for women who received only Xeloda.

Targeted drugs Herceptin and Tykerb are major advances in the fight against breast cancer -- for the 20 percent of diagnosed women with the aggressive HER2 positive disease -- and they are also quite expensive. While some say they are worth every penny if they offer a cure, others question the cost if they only delay the disease progression for a few months. Such was the case in this study.

Perhaps the greatest potential for these agents is for use before breast cancer spreads, when they may improve the chance for a cure.

Someone once told me to think of cancer as a chronic condition -- an illness like diabetes or asthma that may linger for life and may require continual treatment. And while battling cancer, perhaps for life, I should just hope that medical advances occur and new treatments become available. And maybe, just maybe, the science of medicine will decrease by leaps and bounds the number of people who die from cancer.

During my own battle with cancer -- which has been 18 months long -- two new breast cancer drugs have hit the scene with rave reviews from researchers and medical professionals. This is good news for me because my type of breast cancer makes me a candidate for both drugs. Herceptin is one of these drugs -- given to women who are HER-2/neu positive -- that's me -- and over express a protein that makes the tumor aggressive. Herceptin is received over 52 weeks -- and I go every three weeks for a 90-minute infusion of this clear liquid that causes me really no side effects at all. It can be toxic to the heart but monitoring tests have revealed that my heart is not suffering at this time. And with just three more infusions to go -- one this Wednesday -- I will likely encounter no adverse reactions to this potentially life-saving drug.

And now Tykerb is making headlines. Tykerb, suggested for use with advanced breast cancer and manufactured by British-based GlaxoSmithKline PLC, is an experimental drug that delays the growth of tumors nearly twice as long as standard chemotherapy in patients who no longer respond to Herceptin. This finding, reported this past Saturday at a meeting in Atlanta of the American Society of Clinical Oncology, confirms initial findings about the promise of this drug -- that like Herceptin, made by Genentech, precisely targets tumors without killing lots of healthy cells. The difference between the two drugs is that Herceptin blocks the protein on the cell's surface and Tykerb does it inside the cell -- blocking a second abnormal protein too. And while Herceptin is given intravenously, Tykerb is given in pill form -- which may make it cheaper and easier to use.

While now part of an international study, Tykerb may be available to women in the United States later this year. And it perhaps will be offered in conjunction with Herceptin or instead of Herceptin for women with advanced breast cancer.

I hope I do not ever need Tykerb -- and that Herceptin alone will be enough for me -- but it is comforting to know that there is something else out there. Something that if necessary, just might help me live with this potentially chronic condition called cancer.

GlaxoSmithKline announced it has received positive data from an interim analysis of its Phase III trial of Tykerb in advanced breast cancer, and as such, ended enrollment for the trial after it found Tykerb in combination with Xeloda delayed the time to disease progression by more than 50 percent, compared to Xeloda alone.

None of the breast cancer patients in the trial had responded to Herceptin or other drugs.

“We are extremely encouraged by this data which suggest that Tykerb may offer significant benefit as an oral medication in combination with chemotherapy for patients with advanced or metastatic breast cancer, and whose disease has progressed on previous treatment regimens, including Herceptin,” said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GlaxoSmithKline.

At this time, Tykerb is an experimental drug that does not have regulatory approval in any country for any use outside of clinical trials. GlaxoSmithKline plans to file marketing applications for Tykerb with the Food and Drug Administration and European regulators in the second half of the year.