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Merck Says FDA Accepts Its SBLA For Keytruda For Treatment Of Head & Neck Cancer

Source: www.finchannel.comAuthor: Fin Channel News Editorial Staff The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on April 13 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of Aug. 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program, according to Merck. “Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making KEYTRUDA available to these patients.” Merck currently has the largest immuno-oncology clinical development program in head and neck cancer and is advancing multiple registration-enabling studies with KEYTRUDA as a single agent and in combination with chemotherapy. *This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness [...]

Charlotte Parker2016-04-13T11:58:01-07:00April, 2016|Oral Cancer News|

Nivolumab Could Change Head and Neck Cancer Treatment Paradigm

Source: www.Targetedonc.comAuthor: Laura Panjwani "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer." - Robert Ferris, MD, PhD With the phase III CheckMate-141 trial being stopped early due to the anti–PD-1 agent nivolumab having met its primary endpoint of overall survival improvement in head and neck cancer, Robert Ferris, MD, PhD, couldn't be more elated. "This is what I've devoted my career to, and it is gratifying to see that really come to pass," said Ferris, professor and chief, Division of Head and Neck Surgery, vice chair for Clinical Operations, associate director for Translational Research, and coleader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, in an exclusive interview with Targeted Oncology. "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer. There is now hope for a lot of patients and physicians who have been frustrated by this difficult-to-treat disease. This opens up a whole new class of therapies for this population." Ferris, who acted as cochair/coprimary investigator for the trial alongside Maura Gillison, MD, PhD, Ohio State University, said the trial pitted nivolumab against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in patients with platinum-refractory squamous cell carcinoma [...]

Charlotte Parker2016-02-16T09:24:23-07:00February, 2016|Oral Cancer News|

NCI-designated Cancer Centers Urge HPV Vaccination for the Prevention of Cancer

Source: www.medicine.wustl.eduAuthor: Washington University School of Medicine in St. Louis Staff Approximately 79 million people in the United States are currently infected with a human papillomavirus (HPV) according to the Centers for Disease Control and Prevention (CDC), and 14 million new infections occur each year. Several types of high-risk HPV are responsible for the vast majority of cervical, anal, oropharyngeal (middle throat) and other genital cancers. The CDC also reports that each year in the U.S., 27,000 men and women are diagnosed with an HPV-related cancer, which amounts to a new case every 20 minutes. Even though many of these HPV-related cancers are preventable with a safe and effective vaccine, HPV vaccination rates across the U.S. remain low. Together we, a group of the National Cancer Institute (NCI)- designated Cancer Centers, recognize these low rates of HPV vaccination as a serious public health threat. HPV vaccination represents a rare opportunity to prevent many cases of cancer that is tragically underused. As national leaders in cancer research and clinical care, we are compelled to jointly issue this call to action. According to a 2015 CDC report, only 40 percent of girls and 21 percent of boys in the U.S. are receiving the recommended three doses of the HPV vaccine. This falls far short of the goal of 80 percent by the end of this decade, set forth by the U.S. Department of Health and Human Service’s Healthy People 2020 mission. Furthermore, U.S. rates are significantly lower than those of countries such as [...]

Charlotte Parker2016-02-04T12:35:06-07:00February, 2016|Oral Cancer News|

FDA Clears First Tobacco Product for Marketing

For the first time since it was given the power to regulate tobacco, the US Food and Drug Administration (FDA) has authorized marketing of a new product. The agency said that eight new smokeless snus products, to be sold in the United States under the "General" brand name by Stockholm-based Swedish Match AB, are now authorized under the premarket tobacco application pathway, which was established by the 2009 Family Smoking Prevention and Tobacco Control Act. Snus cannot be marketed as "FDA-approved," however. "Today's action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed, as long as the public health can be protected," said Mitch Zeller, director of the FDA's Center for Tobacco Products, in a statement. This is the first time any tobacco maker has completed the rigorous premarket tobacco application review process at the agency; others have had products approved by proving they are substantially equivalent to what is already on the market. The agency said that Swedish Match provided evidence that "these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively." The agency also agreed with the company that snus' availability would not result in substantial new use, delay quit attempts, or attract ex-smokers. Swedish Match had been seeking separately to remove warnings that snus is harmful, but the agency has not yet ruled on that request. In that separate application, Swedish Match was seeking to have the 10 types of snus it [...]

Charlotte Parker2015-11-13T15:25:42-07:00November, 2015|Oral Cancer News|

SA Developed Melanoma Drug Now Seen Effective in Fighting Lung Cancer

Source: www.woai.comAuthor: News Radio 1200 WOAI Staff Keytruda, a cancer drug developed largely at San Antonio's START Center, has already proven to be effective in treating advanced melanoma to the point that it is the major part of former President Jimmy Carter's treatment. Now, News Radio 1200 WOAI reports Keytruda has been given 'fast track' approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States. Dr. Amita Patnaik, a researcher and oncologist at START who helped develop the drug, says the impact of Keytruda on lung cancer patients has been amazing. "Close to 40% of those patients will receive a response," she said. "And of those patients who receive a response, about 80% of those patients will have a long term response." The life saving potential of Keytruda in fighting non small cell lung tumors is obvious. An estimated 221,000 Americans are diagnosed with lung cancer each year, and 158,000 die of the disease annually. Dr. Patnaik says Keytruda is becoming the most successful of what are known as 'targeted therapies,' drugs which trigger the body to take action to fight the cancer. She says both melanoma and lung cancer work essentially the same way to undermine the body's defenses. "The commonality between melanoma and lung cancer is there is a supressive effect of the cancer on the immune system." She says Keytruda essentially overrides that supressive effect, prompting the body to restart its natural immune defenses and fight the [...]

Charlotte Parker2015-10-06T11:11:27-07:00October, 2015|Oral Cancer News|

The Cost of Cancer Drugs

Source: www.cbsnew.comAuthor: Lesley Stahl The following is a script of "The Cost of Cancer Drugs" which aired on October 5, 2014, and was rebroadcast on June 21, 2015. Lesley Stahl is the correspondent. Richard Bonin, producer. Cancer is so pervasive that it touches virtually every family in this country. More than one out of three Americans will be diagnosed with some form of it in their lifetime. And as anyone who's been through it knows, the shock and anxiety of the diagnosis is followed by a second jolt: the high price of cancer drugs. They are so astronomical that a growing number of patients can't afford their co-pay, the percentage of their drug bill they have to pay out-of-pocket. As we first reported in October, this has led to a revolt against the drug companies led by some of the most prominent cancer doctors in the country. Dr. Leonard Saltz: We're in a situation where a cancer diagnosis is one of the leading causes of personal bankruptcy. Dr. Leonard Saltz is chief of gastrointestinal oncology at Memorial Sloan Kettering, one of the nation's premier cancer centers, and he's a leading expert on colon cancer. Lesley Stahl: So, are you saying in effect, that we have to start treating the cost of these drugs almost like a side effect from cancer? Dr. Leonard Saltz: I think that's a fair way of looking at it. We're starting to see the term "financial toxicity" being used in the literature. Individual patients are going into [...]

Oral Cancer Foundation News Team - A2015-06-22T11:00:30-07:00June, 2015|Oral Cancer News|

FDA Advisory Committee hesitates to endorse message of safe smokeless tobacco

Source: www.medpagetoday.com Author: Shannon Firth An FDA advisory panel were reluctant to recommend a gentler warning label for one brand of smokeless tobacco products at a committee hearing on Friday. Swedish Match North America (SMNA), the first company to be considered for a modified risk tobacco designation by the FDA, is asking to replace a current label warning, "This product is not a safe alternative to cigarettes," with this: "Warning: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes." It also wants to drop warnings required for other smokeless tobacco products about oral cancers, tooth loss, and gum disease. In a key vote, the eight-member FDA's Tobacco Products Scientific Advisory Committee split 4-4 on whether the claim that snus offer a "substantially lower risk" claim relative to cigarettes is justified. Many members said the health risks were lower for certain tobacco-related illnesses, but not for all health concerns. Those who disputed the claim argued that it could not be taken as a "global statement" -- as there are known risks to pregnant women and uncertain risks for adolescents. As for the proposed label change, the whole committee agreed that the sponsor's statements would not suffice. Gary Giovino, PhD, chair of the department of Community Health and Health Behavior at the State University of New York at Buffalo, felt the statement was "dismissive of the health risks." The word "but" in any sentence seems to negate the first half, he said. Snus is a [...]

Oral Cancer Foundation News Team - A2015-04-12T07:26:40-07:00April, 2015|Oral Cancer News|

FDA Approves Vaccine That Covers More HPV Strains

Source: webmd.comAuthor: E J Mundell, HealthDay Reporter WEDNESDAY, Dec. 10, 2014 (HealthDay News) -- The U.S. Food and Drug Administration last Wednesday approved a new vaccine with expanded protection against the human papillomavirus (HPV), by far the leading cause of cervical and certain other cancers. The agency said that Gardasil 9 can shield users against nine strains of the virus, compared to the four strains covered by Gardasil, the Merck & Co. vaccine approved in 2006. Merck also makes Gardasil 9. "Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers," the FDA said in an agency news release. "Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the release. "The approval of Gardasil 9 provides broader protection against HPV-related cancers." The U.S. Centers for Disease Control and Prevention currently recommends the HPV vaccine for boys and girls at age 11 or 12, so they are protected before being exposed to the sexually transmitted virus. One other HPV vaccine, Cervarix, was also approved by the FDA in 2009. Cervarix is made by GlaxoSmithKline and protects against two HPV strains strongly linked to cancer, HPV 16 and 18. According to the FDA, the approval of Gardasil 9 was based on a clinical trial involving more than 14,000 girls and women aged 16 to 26 who were not infected with HPV at [...]

Charlotte Parker2014-12-16T17:11:06-07:00December, 2014|Oral Cancer News|

E-cigarette laws may be harder to regulate than originally thought

Source: apnews.com or ap.orgAuthor: Summer Ballentine & Michael Felberbaum JEFFERSON CITY, Mo. (AP) - In a rush to keep electronic cigarettes out of children's hands while the federal government creeps forward with a proposed national ban for minors, experts say that many states are passing laws that could mean fewer restrictions on the nicotine devices later. Lawmakers last month made Missouri the 41st state to outlaw selling e-cigarettes to minors. Age restrictions have wide support, but Gov. Jay Nixon and public health advocates opposed a piece of the legislation that prevents tobacco taxes or regulations from being imposed on the electronic devices, which heat liquid nicotine into an inhalable vapor. E-cigarette makers have been in a tug-of-war with state and federal governments since the battery-powered devices first were sold in the U.S. in 2007. A 2009 law gave the U.S. Food and Drug Administration the power to regulate a number of aspects of tobacco marketing and manufacturing. It first said it planned to assert authority over e-cigarettes in 2011, but it hasn't yet done so. In April, the FDA for the first time proposed a set of regulations for e-cigarettes, including banning sales to minors and requiring health warning labels, as well as approving new products. The agency has said its proposal sets a foundation for regulating the products but the rules wouldn't immediately ban the wide array of flavors of e-cigarettes or curb marketing on places like TV. In the absence of regulation, members of Congress, state leaders and public [...]

Charlotte Parker2014-10-07T13:01:37-07:00October, 2014|Oral Cancer News|

Top cancer organizations push for FDA to regulate all tobacco products

Source: medicalexpress.comAuthor: Staff The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), in a joint letter responding to a proposal by the U.S. Food and Drug Administration (FDA) to extend its regulatory authority over tobacco products, today urged the agency to regulate electronic cigarettes (e-cigarettes), cigars, and all other tobacco products and to strengthen the proposed regulations for newly deemed products. "There is no safe form of tobacco use," said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. "Tobacco is the leading cause of preventable deaths in the United States, and among its dire health consequences are 18 different types of cancer. It is imperative that the FDA takes action to regulate all tobacco products. The future health of the American people, in particular our nation's children, depends on it." The AACR and ASCO applauded the FDA's proposal to regulate e-cigarettes. "We believe it is vitally important for the FDA to begin regulating these products, especially because we don't know much about the health effects of e-cigarette use. We are also quite concerned that e-cigarettes may increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or that they will discourage smokers from quitting," said Peter P. Yu, MD, FASCO, president of ASCO. "There are insufficient data on the long-term health consequences of e-cigarettes, their value as tobacco cessation aids, or their effects on the use of conventional cigarettes. Any benefits of e-cigarettes are most likely to be realized [...]

Charlotte Parker2014-08-13T09:48:45-07:00August, 2014|Oral Cancer News|