FDA – Page 9 – Oral Cancer News

FDA approves GlaxoSmithKline’s Cervarix

Source: Philadelphia Business Journal Author: John George The Food and Drug Administration granted marketing approval Friday to Cervarix, the cervical cancer vaccine developed by GlaxoSmithKline. The London pharmaceutical company, which has major operations in the Philadelphia region, said the vaccine will be on the market before the end of the year. The FDA approved the drug for use in women and girls ages 10 to 25. GlaxoSmithKline (NYSE:GSK) will have a challenge taking market share away from Merck & Co. Inc. (NYSE:MRK), which launched its cervical cancer vaccine Gardasil in 2006. Gardasil had worldwide sales of $1.4 billion for Merck last year. Cervarix, which was previously approved in markets outside the United States including Europe, Japan and Australia, had sales of more than $200 million in 2007.

Charlotte Parker2009-10-16T10:56:58-07:00October, 2009|Oral Cancer News|

Giving Gardasil to boys not worth the cost?

Source: HealthDay.com Author: Steven Reinberg But other experts dispute finding, and say young men need protection from STDs THURSDAY, Oct. 8 (HealthDay News) -- The cost of giving boys the human papillomavirus (HPV) vaccine would outweigh any health benefit, researchers say. Last month, a U.S. Food and Drug Administration panel recommended expanding use of the Gardasil vaccine to males aged 9 to 26 to protect them from genital warts, but the cost effectiveness of such a program was unclear at the time. But researchers from the Harvard School of Public Health conducted such an analysis comparing a girls-only vaccination program with a co-ed vaccination program. Currently, Gardasil is approved for girls aged 9 and over to protect them from cervical cancer. "This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money," said lead researcher Jane Kim, an assistant professor of health decision science. The report is published in the Oct. 9 online edition of the British Medical Journal. Vaccination was considered a good value if cost-effectiveness ratios ranged from $50,000 to $100,000 per quality-adjusted life year, meaning the cost of the vaccine vs. the number of added years someone would gain by getting the vaccine. Assuming 75 percent coverage and lifelong protection, the researchers found routine vaccination of 12-year-old girls was a good value at less than $50,000 per quality-adjusted life year. However, adding preadolescent boys increased the cost-effectiveness ratio [...]

Charlotte Parker2009-10-12T11:54:27-07:00October, 2009|Oral Cancer News|

CDC finds poisons in dissolvable tobacco products

Source: Notobacco Author: Staff Since the beginning of this year, Indianapolis has been a test market for new dissolvable tobacco products, mostly from Camel. These are smokeless, spit-free, made from finely milled tobacco, and held together by food-grade binders. They look like breath mints, breath strips, or toothpicks, and are designed to be placed in the mouth, on the tongue or between the cheek and gum, where they dissolve to release tobacco. Dissolvable tobacco products are now available in Daviess County in the form of Stonewall dissolvable tablets. The manufacturer, Star Scientific, states that Stonewalls are designed for heavy smokers and spit tobacco users. This company also makes Ariva brand dissolvable tablets. Indiana Tobacco Prevention and Cessation agency feels the tobacco companies are illegally using Hoosiers as unwitting participants in a potentially dangerous clinical trial of these products since they were not tested for safety before being sold to the public, as food products, drugs, and cosmetics would be. Dissolvable tobacco products may contain up to three times the amount of nicotine found in one cigarette. A cigarette smoker typically takes in about 1 milligram of nicotine. Camel dissolvable products are said to deliver about 0.6 to 3.1 milligrams of nicotine each, Ariva tablets have about 1.5 millgrams of nicotine each, and Stonewall tablets have about 4 milligrams of nicotine each. People who use these products may get a higher dose of nicotine than they are used to, possibly resulting in nicotine poisoning, which manifests through adverse reactions such as tremors, [...]

Charlotte Parker2009-10-06T20:21:43-07:00October, 2009|Oral Cancer News|

IsoRay announces Cornell Medical Center adopts Cesium-131 to treat head and neck cancer

Source: www.businesswire.com Author: press release IsoRay, Inc. (Amex: ISR) announced today that on August 5, 2009, Dr. Bhupesh Parashar from the Department of Radiation Oncology, Dr. David Kutler of the Department of Otorhinolaryngology, and Dr. Jason Spector of the Department of Plastic Surgery at Weill Cornell Medical Center performed the world’s first Cesium-131 implant for a recurrent head and neck cancer (buccal mucosa). The implant was performed using Vicryl®-embedded seeds on a 66-year-old patient who had received a full course of radiation to the head and neck several years ago. Cesium-131 was chosen for its short half-life and the higher dose rate. The patient tolerated the implant procedure well, and has had no adverse effects that can be attributed to the use of Cs-131 seeds. There is no evidence of cancer recurrence to date. Dr. Parashar stated, “We are very pleased to date with this patient’s progress. Having Cs-131 with its combination of short half-life and high energy gave us another option for treating this patient’s recurring buccal mucosa cancer.” Dr. Dattatreyudu Nori, the Chairman of the Department of Radiation Oncology at Weill Cornell Medical Center, and a pioneer in the field of brachytherapy, performed some of the initial Cesium-131 prostate implants in 2005. Until now clinical experience with Cesium-131 has been focused on prostate cancer and ocular melanoma. However, Cesium-131 has been cleared by the FDA for use in the treatment of malignant disease (e.g., prostate, ocular melanoma, head and neck, lung, brain, breast, etc.) and may be used [...]

Oral Cancer Foundation News Team - A2009-09-29T04:12:27-07:00September, 2009|Oral Cancer News|

Flavored cigarette ban takes effect 9/22

Source: MSN.com Author: Karen Pallarito New federal law may help deter young smokers, health advocates say TUESDAY, Sept. 22 (HealthDay News) -- Young people who enjoy a hint of vanilla, berry or chocolate when they light up are about to have their favorite smokes snuffed out. A new federal law banning fruit- and candy-flavored cigarettes takes effect Sept. 22. The prohibition is part of the Family Smoking Prevention and Tobacco Control Act, legislation that grants the U.S. Food and Drug Administration the authority to regulate tobacco products. President Barack Obama signed the measure into law June 22. Studies show that flavored cigarettes, which have been around for about a decade, disproportionately appeal to America's youth. Thus, banning the manufacture and sale of kid-friendly flavored cigarettes is a critical step toward deterring young smokers, health advocates said. "Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," FDA Commissioner Dr. Margaret A. Hamburg said in a news release. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our nation's public health." Gregg Haifley, associate director of federal relations for the American Cancer Society Cancer Action Network in Washington, D.C., said, "Banning candy and fruit flavorings in cigarettes can have a significant effect on the reduction of initiation of smoking among youth, as well as reducing the number of youth who go on to regular, [...]

Charlotte Parker2009-09-22T16:48:58-07:00September, 2009|Oral Cancer News|

BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer

Source: PR Newswire Author: Staff WOBURN, Mass., Sept. 15 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses [...]

Charlotte Parker2009-09-16T16:29:05-07:00September, 2009|Oral Cancer News|

BioVex agrees SPA with the FDA for a pivotal phase III study with OncoVEX (GM-CSF) in head and neck cancer

Source: news.prnewswire.com Author: press release BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX . In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are [...]

Oral Cancer Foundation News Team - A2009-09-15T14:20:04-07:00September, 2009|Oral Cancer News|

FDA Advisory Committee recommends approval for use of GARDASIL® in boys and men

Source: www.merck.com Author: press release Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL¨ [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. "Merck has been committed to pursuing the use of GARDASIL in both males and females since the vaccine was discovered over a decade ago," said Peter S. Kim, Ph.D., executive vice president, and president of Merck Research Laboratories. "We are pleased that the Advisory Committee agrees that the data support the use of GARDASIL in boys and men.” The committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in December 2008. The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing vaccines. Merck expects a decision from the FDA in the fourth quarter of 2009 after the agency has completed its review of Merck's application. “Today's discussion with the Advisory Committee brings the public health community closer to being able to provide GARDASIL to both men and women," said Anna R. Giuliano, Ph.D., Moffitt Cancer Center. GARDASIL has been approved for use in the U.S. since June 2006 and is [...]

Oral Cancer Foundation News Team - A2009-09-09T21:02:25-07:00September, 2009|Oral Cancer News|

Clove cigars avoid ban on flavored cigarettes

Source: online.wsj.com Author: staff The nation's top distributor of clove cigarettes is offering fans a new way to get their fix after the spice-flavored cigarettes are banned at the end of this month—cigars. The new filtered cigars—close to the size of a cigarette and flavored with clove, vanilla and cherry—allow Kretek International Inc., which imports Djarum-brand tobacco products from Indonesia, to avoid new federal laws banning flavored cigarettes other than menthol. The ban on flavored cigarettes, which critics say appeal to teenagers, doesn't include cigars. The difference? Cigarettes are wrapped in thin paper, cigars in tobacco leaves. While the cigars also are made with a different kind of tobacco, the taste is similar. The cigars come 12 to a pack, rather than 20 for cigarettes, but cost nearly half as much. The ban is one of the first visible effects of a new law signed by President Barack Obama in June that gives the Food and Drug Administration wide-ranging authority to regulate tobacco, though it can't ban nicotine or tobacco outright. The new law gives the FDA the power to ban other products like flavored cigars, but that hasn't happened yet. Whether the cigars are truly different or just an attempt to circumvent the ban by making superficial changes is in the hands of the FDA, said Matthew Myers, president of the Campaign for Tobacco-Free Kids. "The key is the legislation gives the FDA the authority to respond to these types of frankly totally irresponsible actions,'' Mr. Myers said. Mr. [...]

Oral Cancer Foundation News Team - A2009-09-08T17:30:00-07:00September, 2009|Oral Cancer News|

Tobacco giants challenge law

Source: online.wsj.com Author: David Kesmodel, Lauren Etter & Alicia Mundy Reynolds American Inc., Lorillard Inc. and several other tobacco companies filed a lawsuit Monday seeking to block various provisions of a new federal tobacco law on the grounds that the provisions violate the companies' First Amendment rights. The tobacco companies said the recently enacted law, which placed the industry under the oversight of the Food and Drug Administration, sharply restricts the companies' right to advertise their products to adult tobacco users. The companies object to such provisions as a requirement that cigarette makers expand the size of warning labels so that they cover the top half of the front and back of cigarette packs, and include graphic images such as diseased lungs. This change, they say, would leave manufacturers with only a small and often-obscured portion of a cigarette pack to print their own messages. The companies also challenged a rule that restricts their ability to publicize the relative health risks of certain products such as smokeless tobacco. The suit was filed against the FDA in a federal district court in Bowling Green, Ky., the home of one of the plaintiffs, Commonwealth Brands Inc. An FDA spokeswoman said the agency doesn't comment on lawsuits. The FDA recently announced that its choice for its "tobacco czar" to run the new tobacco regulation center is Lawrence Deyton, who led antismoking efforts at the Department of Veterans Affairs. Many of the FDA regulations won't take effect until next year and the years that [...]

Oral Cancer Foundation News Team - A2009-09-01T12:13:33-07:00September, 2009|Oral Cancer News|