Roche Stands To Lose Substantial Sales Should Regulatory Bodies Revoke License For Avastin.
Dow Jones Newswire(12/8, Mijuk) reported that should FDA and European regulators revoke the license for Avastin (bevacizumab) as a treatment for breast cancer, then the drug’s maker, Roche Holding AG, may stand to lose more than one billion Swiss francs in sales in 2010. On Dec. 17, the FDA is generally expected to make its decision as to whether Avastin may be used together with certain chemotherapy protocols to treat metastatic breast cancer. Currently, the agency is reviewing new data supplied by Roche.

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FDA review indicates possible association between breast implants and a rare cancer
Agency requesting health care professionals to report confirmed cases
 
The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.
 
The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
 
In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.
 
“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”
 
According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
 
In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.
 
The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.
 
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.
 
The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

• Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online¹ or by calling 800-332-1088.
• Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
• There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.  Although not specific to ALCL, health care providers should follow standard medical recommendations.
• Women should monitor their breast implants and contact their doctor if they notice any changes.
• Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”
 
The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.
 
For more information:
 
ALCL and Breast Implants
² 
Breast Implant Consumer Information³
 

ALCL and Breast Implants Consumer Article

Technorati Tags: alac, breast implants, health

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The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well. 

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination.  For all of the indications for use approved by the FDA, Gardasil’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.  

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.
 

For more information:

Gardasil Product Page

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm237941.htm

Technorati Tags: anal cancer, gardisil, health

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The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Halaven shows a clear survival benefit and is an important new option for women.”

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late-stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

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There is alot of concern as the H1N1 pandemic is not letting up.
With the release of the H1N1 vaccine recently, there is a natural tendency for the public to find cheaper and readily available sources. It is common nowadays for consumers to buy medicine over the internet. However, the authencity and regulated sales of these medicines is virtually impossible to control. Yet people still resort to buying medication over the internet.

Here’s a recent consumer update from the FDA which I will like to share with you:

The Food and Drug Administration (FDA) is informing consumers of—and protecting them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the 2009 H1N1 influenza virus.

Within the past two weeks, FDA has urged caution regarding promotions and Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the H1N1 flu virus enhanced efforts to warn about potentially deceptive H1N1 products, and encourage reporting of suspected criminal activity, with the release of an H1N1 flu fraud widget.
This portable application is embedded in an agency Web page (www.fda.gov/NewsEvents/PublicHealthFocus/ucm186340.htm) and can be copied onto any other Web site or blog.
with the Federal Trade Commission (FTC), issued a warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the H1N1 virus. The letter advises the site’s owners to discontinue marketing the products or face legal action.

 
Previous Actions
These new measures follow FDA actions earlier this year to protect consumers against Web sites offering unapproved products. These actions included enforcing laws that protect consumers against these sites, and warnings posted through media outreach and a “Fraudulent Products List” posted on FDA’s Web site at www.accessdata.fda.gov/scripts/h1n1flu/.

Since May 2009, FDA has warned more than 75 Web sites to stop the sale of more than 135 products with fraudulent H1N1 influenza virus claims.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Unless these products and the claims they make are proven to be safe and effective, they will not prevent the transmission of the virus or offer effective remedies against infection. Furthermore, they can make matters worse by providing consumers with a false sense of protection.”

Buy Only FDA-Approved Products
Consumers are urged to only purchase FDA-approved products from licensed pharmacies located in the United States, and should contact their health professional if they have any questions or concerns about medical products or personal protective equipment.

Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the only two FDA-approved antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus. In addition to their approved labeling, these drugs have been issued Emergency Use Authorizations by FDA that describe specific authorized uses during the H1N1 public health emergency.

Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.

An Assortment of Targeted Products
FDA actively monitors the Internet and, where appropriate, purchases and analyzes drug products. In October 2009, it announced what it found when it purchased and analyzed several products represented online as Tamiflu.

One of these online orders resulted in delivery to FDA of an unmarked envelope postmarked from India. Inside were unlabeled, white tablets taped between two pieces of paper that were found to contain talc and acetaminophen, an active ingredient found in many medicines to help relieve pain and reduce fever. Not found was oseltamivir, the active ingredient of Tamiflu.

The Web site selling this product disappeared shortly after FDA placed the order.

The agency also bought four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites. These products contained various levels of oseltamivir but were not approved for use in the United States. Several did not require a prescription from a health professional.

In actions it announced in June 2009, FDA issued warning letters and advised operators of offending sites to immediately ensure that they weren’t marketing products intended to act against the H1N1 flu virus that have not been cleared, approved, or authorized by the agency.

Among the unapproved, uncleared, or unauthorized H1N1 flu products it targeted at that time were

1)a shampoo said to protect against the H1N1 flu virus
2)a dietary supplement said to protect infants and young children from contracting the virus
3)a “new” supplement said to cure H1N1 flu infection within four to eight hours
4)a spray that claims to leave a layer of ionic silver on one’s hands that kills the flu virus
5)several diagnostic tests that have not been approved to detect the H1N1 flu virus
6)an electronic instrument whose sellers claim uses “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1 viral infection

Work by FDA and the FTC to identify, investigate, and take regulatory action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products will continue. These efforts can include additional legal actions including seizure of products, injunction, or criminal prosecution.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Here’s the link

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