Friday, January 29, 2010

FDA approves expanded use of breast cancer drug

The FDA today approved the expanded use of a breast cancer drug.  Here's the information from the FDA:

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

HER2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells. In hormone positive breast cancer, the presence of certain hormones contributes to breast cancer growth. In HER2-positive breast cancer, stimulation of the HER2 receptor contributes to cancer cell growth. Breast cancer is the second leading cause of death among women. More than 192,000 women will be diagnosed with breast cancer this year.

“This drug combination of Tykerb plus Femara provides women being treated for advanced breast cancer with an important treatment option. This entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells’ ability to grow or spread,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, in the FDA’s Center for Drug Evaluation and Research.

Women with HER2-positive disease receiving the Tykerb plus Femara combination more than doubled the time they lived without the cancer progressing compared with those receiving Femara alone (35 weeks vs. 13 weeks). Women in the company sponsored study were randomized to receive Tykerb plus Femara or Femara alone. It is too early to determine whether an improvement in overall survival will be observed in the clinical trial.

Tykerb works by depriving tumor cells of signals needed to grow. Tykerb enters the cell and blocks the function of the HER2 protein.

Tykerb was initially approved in combination with a chemotherapy drug, Xeloda (capecitabine) in 2007. This combination was used to treat women with advanced breast cancer tumors with the HER2 protein who had received prior treatment with chemotherapy drugs, including an anthracycline and a taxane, and Herceptin (trastuzumab), an anti-cancer antibody used to treat HER2-positive advanced breast cancer.

Safety information from this study was consistent with previous Tykerb clinical studies in advanced breast cancer. The most commonly reported side effects of the combination were diarrhea, rash, nausea and fatigue. Treatment with Tykerb also has been associated with decreases in heart function, liver damage, and lung tissue inflammation. Fetal harm may occur if used to treat advanced breast cancer in pregnant women. Patients should talk to their health care provider about the potential side effects, drug interactions, and other medical conditions.

Sunday, January 24, 2010

Slow the Spread of Winter Germs

It's winter and everyone spends a lot more time indoors. Kids are in school and colds and flu seem to spread through entire communities through schools and workplaces. Eventually, one member of the family is going to come home sick. What can you do to keep the virus from spreading to every member of the family?

The steps are simple and good to practice at all times, but you need to be especially vigilant once the virus steps inside your house.

* Wash your hands - This applies to everyone in the house, not just the ill member. During the course of the day, anyone can touch a surface that the sick family member has touched, so washing hands often will help prevent this method of infection.

* Disinfect surfaces - the telephone, doorknobs, railings, tables - anything that is regularly touched by every family member. If the sick person is a child, wash toys too. If there is a stomach virus going around, be sure to disinfect all bathroom surfaces.

* Keep hand sanitizer handy - encourage everyone to use it whenever they touch surfaces that could harbor germs.

* Limit contact - don't share items like towels and drinking glasses with the sick person.

Remember that the sick person was probably contagious before any symptoms became evident, so don't think you can avoid the germs entirely. However, you can take steps to lower exposure and try to keep the family healthier during this germ-laden season.

Friday, January 15, 2010

Resource for Women with Bladder Control Problems

A new resource from the National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC), for women with bladder control problems is available from the National Institutes of Health (NIH).   Women with bladder control problems can learn about treatments and techniques to help them manage their condition.

This NIH News Release is now available online.


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