Breast cancer drug Herceptin has been approved in Europe for use with hormonal therapy for postmenopausal patients with HER2 and hormone receptor positive metastatic disease.

Herceptin, made by Swiss drugmaker Roche Holding AG, is already approved in Europe for early and metastatic HER2-positive breast cancer.

This new approval is based on data from an international late stage clinical trial showing the combination of Herceptin with hormonal therapy doubled the median progression-free survival time.

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."

A liquid form of the hormonal therapy Tamoxifen is now available for women who have difficultly swallowing pills.

Soltamox, the brand name for liquid Tamoxifen, was approved by the FDA in October. Some women develop dysphagia, difficultly or painful swallowing, during or after chemotherapy and radiation treatments. These women might cut or crush up their pills in order to be able to swallow them. This can impact how the body absorbs the medication and the overall effectiveness of Tamoxifen.

Some women skip doses or avoid taking the pills all together. The new delivery method for Tamoxifen may help you if you suffer from dysphagia and your doctor recommends that you take hormonal therapy.

The medication is sugar free, clear and colorless. It tastes and smells like licorice and aniseed. Liquid and pill form Tamoxifen have the same side effects.

At one time, patients with blood cancers were treated with harsh drugs, like interferon or hydroxyurea, yet only two to three percent would ever achieve any sort of remission. Many would suffer such extreme side effects from these drugs they would stop taking the medication early, decreasing even further their potential odds for survival.

The fate of these patients is changing. And the proof is in print -- in today's issue of the New England Journal of Medicine.

It all began with the study of a highly targeted molecular therapy called STI571 -- designed to block the genetic aberration that gives rise to chronic myeloid leukemia (CML), a disease that affects about 6,000 Americans every year. A clinical trial followed, and a compound marketed by the drug company Novartis emerged. Today, this compound is know as Gleevec.

In the clinical trial of Gleevec, 1,106 CML patients were randomly chosen to receive either Gleevec or Interferon. Early results were so encouraging that all but three percent of the participants using Interferon switched to Gleevec. Five-year survival rates were 89 percent. And 93 percent of patients saw no progression to the acute phase of the disease. Many patients witnessed their blood counts return to normal, and a large number experienced a reverse in the gene mutation that causes CML. Virtually no one reported side effects while using the drug.

Despite a rare reaction that can cause heart failure, Gleevec has now been approved by the FDA for the treatment of six other rare, life-threatening disorders. And other drugs similar in nature to Gleevec are hitting the scene. Some believe long-term suppression of CML will come from a cocktail of these types of drugs.

For now, Gleevec -- on its own -- is a success story.

In September of 1998, the FDA approved Herceptin to treat breast cancer after it had become metastatic. Yesterday the FDA approved Herceptin's use for women diagnosed with breast cancer just after surgery. The drug is already widely prescribed for adjuvant therapy even without the FDA's approval, a practice called off-label use. Off-label use means that a prescription drug is being prescribed for a purpose not listed on the product's label. This is a common and acceptable practice by doctors and the Food and Drug Administration.

Clinical trials were conducted that showed women who received Herceptin (trastuzumab) given along with chemotherapy had fewer relapses than those who only received chemotherapy. Twenty to thirty percent of women diagnosed with breast cancer have this genetic alteration of the HER2 gene and could benefit by being treated with Herceptin.

Last week The Food and Drug Administration (FDA) approved Taxotere (docetaxel) for the use in combination with cisplatin and fluorouracil prior to radiation therapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck.

A trial was conducted that included 358 patients with previously untreated, inoperable, locally advanced head and neck cancer. The patients were divided into two groups. One group received Taxotere in combination with cisplatin and fluorouracil and the other group received only cisplatin and fluorouracil. Chemotherapy was administered before radiation treatments. The patients that received the Taxotere experienced a longer survival time and a longer time to disease progression.

Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research said "Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patient's survival."

Lymphomas are cancers of the lymphatic system. There are two general types of lymphomas. Hodgkin's Disease, named after Dr. Thomas Hodgkin who first recognized the disease in 1832, and Non-Hodgkin's Disease (NHL). The difference between these two cancers is that Hodgkin's disease contains specific cells that are not seen in any other lymphomas. Non-Hodgkin's lymphoma is actually a group of about ten different types. One rare type of NHL is called cutaneous T-cell lymphoma (CTCL).

CTCL accounts for about one in twenty cases of NHL. It mainly affects the skin and can often mimic several skin disorders. It is caused by the uncontrolled growth of a type of white blood cell in the skin called a T-cell.

The Food and Drug Administration approved the drug Zolinza on Friday to treat cutaneous T-cell lymphoma. The FDA says drug should be used if there is a recurrence of CTCL or if the disease persists or gets worse with other medications.

Zolinza is thought to silence some genes that when left unchecked allow cancerous cells to grow. It is a new class of cancer drugs called histone deacetylase inhibitors. At the current time the cancer.gov website lists 36 clinical trials involving Zolinza alone or in combination with other drugs.

Merck & Co. Inc, the maker of Zolinza, plan on studying the drug as a tumor-fighting treatment for other cancers, including the breast and lung cancer.

Yesterday the Food and Drug Administration approved the drug Vectibix for patients who have metastatic colon cancer. Vectibix is to be given by IV following standard chemotherapy treatments. The FDA approved the drug after it showed effectiveness in slowing tumor growth and, in some cases, reduced tumor size.

Steven Galson, MD,MPH, the director of the FDA's Center for Drug Evaluation and Research said "This approval adds a treatment option for patients with an advanced stage of a disease that can be life threatening".

Vectibix is a monoclonal antibody, scientists can make monoclonal antibodies that react with specific antigens on certain types of cancer cells. As researchers discover more cancer associated antigens, they will be able to direct monoclonal antibodies against more and more cancers.

The Food and Drug Administration (FDA) has issued a health warning to consumers that drinking high-strength hydrogen peroxide products sold online are extremely corrosive and can lead to stomach irritation or ulcers; and injecting the solution intravenously could lead to blood vessel inflammation, bubbles in blood vessels and potentially life-threatening allergic reaction.

In addition, the FDA has issued warnings to two Texas-based firms, DFWX and Frad 35 Inc., who are illegally selling 35 percent hydrogen peroxide products to treat AIDS, cancer, emphysema and other serious diseases.

To understand the strength of the hydrogen peroxide the FDA is referring to, high-strength hydrogen peroxide is 35 percent while the strength of hydrogen peroxide solution sold over-the-counter for disinfecting wounds is only 3 percent.

According to the news release, Donald Worden, owner of Frad 35 Inc., said he would continue selling his 35 percent hydrogen peroxide product and that his website provided links to information about potential medical uses but that he was not promoting his products for that purpose.

The FDA has issued a warning about this product. You have been warned.

Eli Lilly and Company has announced that the United States Food and Drug Administration, FDA, has approved gemcitabine HCl, known as Gemzar, in chemotherapy cancer treatments for women facing recurrent ovarian cancer. Gemzar is only approved for the treatment of ovarian cancer when used in combination with carboplatin, another chemotherapy drug currently used to treat women with advanced and recurrent ovarian cancer.

Gemzar is already approved as a cancer drug in the treatment for non-small cell lung cancer, pancreatic cancer and metastatic breast cancer. Clinical studies reviewed by the FDA showed that patients treated with a combination of Gemzar and carboplatin experienced a significant improvement in survival and response rates compared to carboplatin alone.

"Ovarian cancer is marked by one of the highest recurrence rates of all women's cancers," states Dr. Robert Ozols, of the Fox Chase Cancer Center. "The Gemzar combination can help us aggressively address this recurrent disease with increased clinical efficacy and generally manageable side effects."

For more information about the chemotherapy drug Gemzar, visit Eli Lilly's Gemzar website.

Right here in Gainesville, Florida -- at the University of Florida to be exact -- the vaccine for cervical cancer is now available for college students. This vaccine -- called Gardasil -- could prevent women from contracting the human papillomavirus (HPV) which can cause cervical cancer and genital warts. Almost 30 of the more than 100 different strains of HPV are sexually transmitted -- and sometime in their lives, 50 percent of sexually active men and women will contract genital HPV infection. Many will not know they have it and will spread it unknowingly to sexual partners. Protection can come in the form of Gardasil which is approved for use in women between the ages of 9 and 26.

Women who are not sexually active are the best candidates for this vaccine because it is clear that they have not yet been infected. The vaccine is not effective for women who already are infected with HPV. And those who don't know if they are infected can determine if they have HPV through a routine Pap smear. If they do not have HPV, the vaccine is indicated. Once the vaccine is indicated, it is delivered in three separate doses over a six-month period of time. Each dose costs $120 -- which may discourage students from this option.

About 9,700 women in the United States will develop cervical cancer in 2006 and this cancer will kill 3,700 of these women. This vaccine -- if received well by young women who can afford it -- should prove a breakthrough in cancer research and prevention.

European women diagnosed with early-stage breast cancer with tumors that over-express the HER2 protein will now be receiving the sought after, and fought for, drug Herceptin. Six years ago, the drug, known to reduce the risk of recurrence of breast cancer by 46 percent, was approved for women with late-stage HER2 breast cancer, but not for women in the early-stages of the same cancer. In the UK, there have been public protests and almost daily headline news over women being denied access to the drug through the universal health care medical coverage plans. Depending on where a woman lived, some breast cancer patients were receiving Herceptin, while other women were not getting the drug.

Joanne Rule, head of UK charity Cancerbackup is quoted as saying, "Breast cancer patients across England and Wales are currently experiencing a dreadful postcode lottery; denied Herceptin because of where they live or how exceptional their lives are deemed to be. This can stop now."

Valeant Pharmaceuticals International announced that the U.S. Food and Drug Administration has approved Cesamet, a synthetic cannabinoid, THC, for treatment of nausea and vomiting associated with cancer chemotherapy in patients when conventional antiemetic treatments have failed. According to the American Cancer Society, approximately 70 to 80 percent of patients undergoing chemotherapy experience nausea and vomiting.

Current medications to relieve the side-effects of nausea and vomiting only work for less than half of cancer patients during chemotherapy. Cesamet as a prescription drug should be available in less than a month. Synthetic THC acts on the brain like the THC in smoked marijuana -- but eliminates having to inhale the otherwise harmful smoke contained in the illegal drug. Recently, the FDA made a public statement that it did not support the use of medical marijuana.