Food and Drug Administration – Page 2

FDA Approves Cetuximab for Late-Stage Head and Neck Cancer

Source: The Oncology Report The Food and Drug Administration on Nov. 7 approved cetuximab as an initial treatment of late-stage head and neck cancer in combination with chemotherapy. Cetuximab, marketed as Erbitux by Bristol-Myers Squibb, is an epidermal growth factor receptor (EGFR) antagonist, administered as an intravenous infusion. Previously, it was approved in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma. It was also approved for use alone in patients with recurrent locoregional disease or metastatic disease whose disease has progressed following platinum-based chemotherapy. The newly approved indication is for the treatment of these recurrent or metastatic patients as an initial therapy in combination with platinum-based therapy with 5-fluorouracil (5-FU), a BMS spokesperson said. (At press time, the company had not yet issued a statement on the approval.) Erbitux was initially approved in 2004 to treat EGFR-positive late-stage colon cancer after patients stopped responding to chemotherapy and was approved in 2006 for the treatment of head and neck cancer. The newly approved indication is for "recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU," according to the revised label, posted on the FDA Web site. The two previously approved indications for head and neck cancer were for "locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy," and for "recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. [...]

Oral Cancer Foundation News Team - A2011-11-09T11:05:16-07:00November, 2011|Oral Cancer News|

Monitoring Tobacco-Specific N-Nitrosamines and Nicotine in Novel Marlboro and Camel Smokeless Tobacco Products: Findings From Round 1 of the New Product Watch

Source: OxfordJournals.org Abstract Introduction: Information on chemical composition of the new oral “spitless” smokeless tobacco products is scarce, and it is not clear whether there is some variability as a function of purchase place or time due to either unintended or intended manufacturing variations or other conditions. Methods: We analyzed tobacco-specific N-nitrosamines (TSNA) and nicotine in Marlboro Snus, Camel Snus, and dissolvable Camel products Orbs, Sticks, and Strips that were purchased in various regions of the country during the summer of 2010. Results: A total of 117 samples were received from different states representing six regions of the country. Levels of unprotonated nicotine in Marlboro Snus and Camel Snus varied significantly by regions, with the differences between the highest and the lowest average regional levels being relatively small in Marlboro Snus (∼1.3-fold) and large in Camel Snus (∼3-fold). Some regional variations in TSNA levels were also observed. Overall, Camel Snus had significantly higher TSNA levels than Marlboro Snus, and Camel Strips had the lowest TSNA levels among all novel products analyzed here. The amount of unprotonated nicotine in the dissolvable Camel products was comparable to the levels found in Marlboro Snus. Conclusions: Our study demonstrates some regional variations in the levels of nicotine and TSNA in Marlboro and Camel novel smokeless tobacco products. Continued monitoring of this category of products is needed as the existing products are being test marketed and modified, and new products are being introduced. This information is particularly important given its relevance to Food and Drug [...]

Oral Cancer Foundation News Team - A2011-10-31T11:13:41-07:00October, 2011|Oral Cancer News|

Kentucky Cancer Center Urges Smokers to Switch to Smoke-Free Tobacco. But is it Really a Better Option?

Source: Yourlife.USAtoday.com In the smoker-heavy state of Kentucky, a cancer center is suggesting something that most health experts won't and the tobacco industry can't: If you really want to quit, switch to smoke-free tobacco. The James Graham Brown Cancer Center and the University of Louisville are aiming their "Switch and Quit" campaign at the city of Owensboro. It uses print, radio, billboard and other advertising to urge smokers to swap their cigarettes for smokeless tobacco and other products that do not deliver nicotine by smoke. Supporters say smokers who switch are more likely to give up cigarettes than those who use other methods such as nicotine patches, and that smokeless tobacco carries less risk of disease than cigarettes do. "We need something that works better than what we have," said Dr. Donald Miller, an oncologist and director of the James Graham Brown Cancer Center, which supports the effort along with the University of Louisville. "This is as reasonable a scientific hypothesis as anybody has come up with and it needs to be tried." The campaign runs counter to the prevailing opinion of the public health community, which holds that there is no safe way to use tobacco. Federal researchers, however, have begun to at least consider the idea that smokers might be better off going smokeless. The National Cancer Institute at the National Institutes of Health says on its website that the use of all tobacco products "should be strongly discouraged," and that there is "no scientific evidence that using [...]

Oral Cancer Foundation News Team - A2011-10-31T10:04:54-07:00October, 2011|Oral Cancer News|

New HPV Study Proves Vaccine’s Effectiveness

Source: Cancer.gov A flurry of new research findings on a vaccine that prevents persistent infections by cancer-causing types of the human papillomavirus (HPV) has confirmed the vaccine's efficacy and opened new avenues for research. The results, published in three separate reports, suggest that the vaccine could be simpler to administer and more affordable than researchers had previously thought—and that the vaccine may also have unexpected benefits. All three studies originate from an ongoing clinical trial of Cervarix in Costa Rica. The new findings could help inform efforts to develop vaccination programs to prevent cervical cancer in countries around the world, the researchers said. "The results from our trial and from other trials are extremely promising for this vaccine," said Dr. Allan Hildesheim of NCI's Division of Cancer Epidemiology and Genetics (DCEG), a leader of the trial. "And they suggest that the impact of the vaccine may go beyond cervical disease." HPV infections can lead to cancers of the anus, vagina, vulva, penis, and some oropharyngeal cancers, in addition to cervical cancer. Cervarix is one of two HPV vaccines currently approved by the Food and Drug Administration to prevent these infections; the other is Gardasil. One of the studies found that fewer than the prescribed three doses of Cervarix may offer the same protection as the full course. If confirmed, this could make vaccination easier to administer and more affordable, factors that are especially important in developing countries that have high rates of cervical cancer. A second study from the Costa [...]

Oral Cancer Foundation News Team - A2011-09-27T11:19:48-07:00September, 2011|Oral Cancer News|

New Study for Cancer Patients to Help Improve the Body’s Ability to Fight Illness

Source: Sign On San Diego A Santa Monica research center will test an experimental therapeutic filtering device being developed by Aethlon Medical on blood taken from cancer patients, the San Diego company said Wednesday. The study will target exosomes, bubbles of protein and RNA molecules excreted by cancerous cells that can block immune system cells from fighting the illness. By removing exosomes from circulating blood, Aethlon officials hope their device will improve the body's ability to fight cancer and the effectiveness of treatments such as chemotherapy. Blood taken from 25 patients with non-small cell lung cancer, prostate cancer, melanoma, sarcoma, and head and neck cancer will be circulated through the Hemopurifier device. In clinical use, blood would be filltered directly from the patient and returned to the body in a similar way to kidney dialysis. However, in the newly announced pre-clinical trial blood will not be returned to patients, Aethlon Chairman and Chief Executive Officer James Joyce said. "If we validate that our Hemopurifier is efficient in capturing exosomes, its possible that we could transition towards a human treatment study to evaluate exosome clearance from the entire circulatory system," he said. The test will be conducted by the Sarcoma Oncology Center, a nonprofit independent research institute focused on cancer therapy development. "This clinical histological study is a critical validation step in Aethlon's Hemopurifier strategy for cancer," said Dr. Sant Chawla, the trial's chief investigator. "The concept of 'subtractive therapy', eliminating a major mechanism of tumor progression and resistance to drugs, [...]

Oral Cancer Foundation News Team - A2011-08-25T09:51:41-07:00August, 2011|Oral Cancer News|

Shortchanging cancer patients

Source: nytimes.com Author: Ezekiel J. Emanuel Right now cancer care is being rationed in the United States. Probably to their great disappointment, President Obama’s critics cannot blame this rationing on death panels or health care reform. Rather, it is caused by a severe shortage of important cancer drugs. Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. They include drugs that are the mainstay of treatment regimens used to cure leukemia, lymphoma and testicular cancer. As Dr. Michael Link, the president of the American Society of Clinical Oncology, recently told me, “If you are a pediatric oncologist, you know how to cure 70 to 80 percent of patients. But without these drugs you are out of business.” This shortage is even inhibiting research studies that can lead to higher cure rates: enrollment of patients in many clinical trials has been delayed or stopped because the drugs that are in short supply make up the standard regimens to which new treatments are added or compared. The sad fact is, there are plenty of newer brand-name cancer drugs that do not cure anyone, but just extend life for a few months, at costs of up to $90,000 per patient. Only the older but curative cancer drugs — drugs that can cost as little as $3 per dose — have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use [...]

Oral Cancer Foundation News Team - A2011-08-07T20:40:33-07:00August, 2011|Oral Cancer News|

Sanford researcher to study new oral cancer therapy

Source: www.mdnews.com Author: public release A new Sanford clinical trial will study the safety and effectiveness of a drug treatment on patients receiving radiation and chemotherapy for head and neck cancer. About three to five percent of all cancers reported in the United States are head and neck cancers. Although the incidence of this type of cancer is relatively low, survival rates are poor — with about a 50 percent of patients surviving over the five-year period following diagnosis, according to John Lee, MD, FACS, Principal Investigator of the trial and a Sanford Clinic Ear, Nose and Throat specialist. Lee’s early research led to the discovery that mice treated with the generic drug dichloroacetate (DCA) responded to cancer therapy 30 percent better. He has received approval from the Food and Drug Administration to begin a clinical trial with patients who are receiving treatment for head and neck cancer. The trial will be open to Sanford patients, and others nationwide. “We are proud of and continue to encourage innovative clinical trials at Sanford that helps us further understand the molecular, cellular and genetic basis of cancer,” said David Pearce, PhD, Vice President, Sanford Research in Sioux Falls. Dr. Lee, who was honored in 2010 by the American Cancer Society for his research, has been studying the link between the Human Papilloma Virus (HPV) and the development of head and neck cancers. His research team has tested the treatment of head and neck tumors in mice finding that factors that enhanced the [...]

Oral Cancer Foundation News Team - A2011-07-16T11:48:35-07:00July, 2011|Oral Cancer News|

New labels may not go far enough

Source: www.denverpost.com Author: Rhonda Hackett How far would you go to stop a killer? Smoking continues to kill more Americans every year than alcohol, AIDS, car accidents, illegal drugs, murders and suicides combined. Tobacco use remains the leading preventable cause of death and the single greatest driver of health-care costs in Colorado. Despite concerted efforts over recent years to educate people about the dangers of tobacco use, 46.6 million American adults smoke, while kids alone are responsible for roughly $2 billion in annual cigarette sales revenues. More than 400,000 people die every year from tobacco use (4,300 in Colorado), while an additional 50,000 adults die as a result of second-hand smoke exposure. More than 8 million Americans currently suffer from tobacco- caused illnesses, resulting in an estimated $96 billion in public and private health care expenditures each year. In Colorado, the tab is about $1.3 billion per year. Simply put, tobacco is the single most lethal and costly legal commodity available in America today. The U.S. Food and Drug Administration has now followed the lead of other developed nations by requiring cigarette packages carry graphic warning labels. FDA Commissioner Margaret Hamburg said at a White House briefing, "We want kids to understand smoking is gross - not cool - and there's really nothing pretty about having mouth cancer." Critics of the warning labels cite the fact that smoking is a legal activity and as such products associated with it should not be subject to government mandate discouraging use. The Institute [...]

Oral Cancer Foundation News Team - A2011-07-03T09:03:04-07:00July, 2011|Oral Cancer News|

Cigarette ads, packages must include oral cancer warnings, says FDA

Source: http://www.healthcanal.com/ Author: Craig Palmer, ADA News staff The Food and Drug Administration will require use of a “cancerous lesion on lip” image in cigarette advertising and packaging for its potential to motivate positive behavioral change, influence youth and young adults in particular and inform the public that cigarettes cause oral cancer. Flexing its regulatory muscle on the second anniversary of the Family Smoking Prevention and Tobacco Control Act, which was signed into law June 22, 2009, the FDA unveiled nine graphic health warnings to be placed on all cigarette packs, cartons and ads no later than Sept. 22, 2012. “The nine new health warning statements and the accompanying graphic images selected by FDA convey information that is factual and uncontroversial,” the agency said in the regulatory notice. The FDA simultaneously announced a public inquiry and request for comments on the public health impact of modified risk tobacco products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. The FDA scheduled a public forum Aug. 25-26 to obtain information on “the scientific issues associated with assessment and ongoing review of MRTPs.” These include smokeless and other products promoted as alternatives to cigarette smoking. The Association supported the 2009 tobacco control law, and has advised the FDA on using the law to shape public tobacco policy. “Dentists are the first line of defense in the war against oral cancer and many other tobacco-related diseases,” the Association told the FDA in [...]

Oral Cancer Foundation News Team - A2011-06-25T08:30:12-07:00June, 2011|Oral Cancer News|

Immunity Drugs Used to Fight Cancer

Source: The Wall Street Journal Scientists are scrambling to develop medications that fight cancer by spurring the body's immune system, a form of treatment that some cancer specialists believe may hold the key to keeping a patient permanently disease-free. The new efforts come in the wake of recent Food and Drug Administration approvals of Dendreon Corp.'s Provenge, an immunotherapy drug used to treat prostate cancer, and Bristol-Myers Squibb Co.'s Yervoy, for melanoma. Other immunotherapy drugs are being developed for a number of other cancers, including lung, brain and kidney cancers. Unlike most traditional therapies that attack a cancer directly, immunotherapy uses the body's own internal defenses to ward off the disease, with the ultimate hope of building up a long-term resistance to the cancer. "If we are ever going to use the word 'cure', the immune system is going to have to come into play," says Stephen Hodi, director of the melanoma center at Dana-Farber Cancer Institute in Boston. One of the ways that cancer survives and ultimately spreads through the body is by exploiting a function in all cells that prevents the immune system from killing them. Researchers have found that cancer cells have multiple methods of avoiding detection and suppressing the immune system's response. "Why would cancer devote so much energy to avoid the immune system if the immune system didn't have the potential to reject the cancer?" says Robert Vonderheide from the Abramson Cancer Center of the University of Pennsylvania. There are big hurdles to advancing the [...]

Oral Cancer Foundation News Team - A2011-06-14T10:26:14-07:00June, 2011|Oral Cancer News|