FDA APPROVES AVASTIN FOR TREATMENT IN SOME PATIENTS WITH CERVICAL CANCER

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer

The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.

Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”

The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.

The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.

The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.

Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.

FDA WARNS OF WART REMOVER FIRES

FROM:  FOOD AND DRUG ADMINISTRATION

Some cryogenic wart removers—which remove warts from the skin by freezing them off—have caught fire during use at home, harming consumers or setting fire to items around the house.

Since 2009, the Food and Drug Administration (FDA)—which regulates wart removers as medical devices—has received 14 such reports about over-the-counter (OTC) wart remover products, which are a mixture of liquid dimethyl ether and propane.

Ten patients have described singed hair, blisters, burns or skin redness, according to FDA nurse consultant Karen Nast, RN. Nearby items have also caught fire.

"The labeling for these products clearly states that they are flammable and should be kept away from fire, flame, heat sources, and cigarettes," Nast notes. In three of the reports, there was a candle nearby, but in the other 11 reports no ignition source was identified. "This is extremely concerning, especially because people may not be aware that everyday household items like curling irons and straight irons can be hot enough to be an ignition source for these products," Nast says.
How to Use These Products

Warts are growths caused by human papillomavirus (HPV) infection. Most treatments using a mixture of liquid dimethyl ether and propane instruct users to follow certain steps.

First, the user presses on the nozzle of a small, pressurized canister (dispenser) containing the mixture. The dispenser releases the mixture, cooled to approximately -40 degrees Celsius, onto an applicator, saturating it. (In some products, the applicator is attached to the cap.) The user presses the applicator on the wart for the amount of time specified in the product directions. An average of three to four treatments is required for warts on thin skin. Warts on calloused skin, such as plantar warts on the soles of the feet, might take more treatments.

In the reports FDA has received, the dispenser generally caught fire when it was releasing the mixture.

HHS ARTICLE ON VACCINATION AGAINST HUMAN PAPILLOMAVIRUS

FROM:   U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

Infection with the human papillomavirus, or HPV, can lead to cancers of the cervix and throat, as well as other body parts. However, a vaccine protects against forms of HPV that most frequently cause cancer.  At the Centers for Disease Control and Prevention, researcher Shannon Stokley:

“The HPV vaccine series consists of three doses, and it’s recommended that all girls and boys receive this vaccine at age 11 or 12.”

Stokley adds that it’s not too late to get vaccinated even up to age 26.  But the vaccine has been out since 2006, and she says coverage is still very low – partly because people don’t know about it and its benefits.