FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine. “Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.” According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women. Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years. The effectiveness of Gardasil is [...]

2018-10-08T09:23:24-07:00October, 2018|Oral Cancer News|

HPV vaccine expanded for people ages 27 to 45

Source: www.nytimes.com Authors: Denise Grady and Jan Hoffman About 14 million women and men become infected with the human papillomavirus each year in the United States, according to the Centers for Disease Control and Prevention. CreditCreditKeith Bedford/The Boston Globe, via Getty Images The HPV vaccine, which prevents cervical cancer and other malignancies, is now approved for men and women from 27 to 45-years-old, the Food and Drug Administration said on Friday. The vaccine is Gardasil 9, made by Merck, and had been previously approved for minors and people up to age 26. It works against the human papillomavirus, HPV, which can also cause genital warts and cancers of the vulva, anus, penis and parts of the throat. The virus has many strains. It is sexually transmitted, and most adults encounter at least one strain at some point in their lives. The vaccine protects against nine strains, including those most likely to cause cancers and genital warts. “Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, said in a statement. The approval was based on a study in women ages 27 to 45, showing that an earlier version of the vaccine was highly effective in preventing persistent HPV infection, genital warts, vulvar and vaginal precancers, cervical precancers and cervical cancers related to the virus types covered by the vaccine. The vaccine’s effectiveness in men ages 27 to [...]

HPV16 vaccine yields added benefit in recurrent throat cancer

Source: www.medpagetoday.com Author: Ian Ingram, Deputy Managing Editor, MedPage Today Adding a tumor-specific vaccine to PD-1 checkpoint inhibition was safe and effective in HPV16-positive patients with recurrent or metastatic oropharyngeal cancer, a small phase II trial found. Among 24 patients treated with nivolumab (Opdivo) and the ISA101 long peptide vaccine, 22 of whom had oropharyngeal cancer, 33% responded and median overall survival was 17.5 months, Cornelis Melief, PhD, of ISA Pharmaceuticals in the Netherlands, reported here at the 4th annual Cancer Immunotherapy Conference. All eight of the responders had oropharyngeal cancer (36%), with two complete and six partial responses. The median duration of response among these patients was 10.3 months, and responses were seen in both platin- and cetuximab-refractory patients, and those refractory to both. Melief noted that one of the partial responders had total clearance of the primary tumor, but a solitary lung metastasis remained, but was stable at 2.5 years. Rate of overall survival at 6 and 12 months was 75% and 70%, respectively. The combination was well tolerated and safe, said Melief, with no increase in the rate of serious adverse events. A randomized trial is planned to confirm the findings. "The results of our trial are among the first clinical data to support the general concept of combining cancer vaccination with immune checkpoint blockade to enhance efficacy of vaccine-activated T cells in the immunosuppressive tumor environment," Melief's group wrote in JAMA Oncology, where the findings were also published. The findings compare favorably to outcomes in a [...]

Oral sex and ‘deep kissing’ linked to increase in HPV-positive head and neck cancer

Source: www.sbs.com.au Author: Amelia Dunn Jake Simpson was 22 when he started to get painful toothaches. Trips back and forth to the dentist couldn’t seem to fix the growing lump at the back of his mouth It came as a total surprise to Jake, his partner Carly, and their newborn son Noah, when oncologists in Brisbane told him he had stage four head and neck cancer, and would need to start treatment immediately. “We didn’t know what any of it meant. He was so young and healthy, we couldn’t believe it,” Carly said. Despite rigorous treatment and surgery that removed more than two-thirds of his tongue, Jake’s cancer was too aggressive and spread to his lungs. He died within eight months of his diagnosis. These cancers, known as oropharyngeal cancers in the back of the tongue and tonsils, are on the rise in young men, and are caused by the sexually transmitted disease HPV – human papillomavirus. While doctors believe it is most commonly passed on through oral sex, some argue it’s now as easy as ‘deep kissing’. “Jake wasn't tested for HPV because it was too aggressive from the day one, but that age bracket that he fell in, more than likely, the cause was HPV,” Carly said. HPV has been dubbed the ‘common cold’ of STDs. Over 80 per cent of Australian adults will get HPV at one point in their lives, and most will clear it without even knowing. But two particular strains, P16 and P18 are [...]

Vaccine, anti-PD1 drug show promise against incurable HPV-related cancers

A tumor-specific vaccine combined with an immune checkpoint inhibitor shrank tumors in one third of patients with incurable cancer related to the human papilloma virus (HPV) in a phase II clinical trial led by investigators at The University of Texas MD Anderson Cancer Center and reported in JAMA Oncology. "That encouraging response rate is about twice the rate produced by PD1 checkpoint inhibitors in previous clinical trials, so these results will lead to larger, randomized clinical trials of this combination," said principal investigator Bonnie Glisson, M.D., professor of Thoracic/Head and Neck Medical Oncology and Abell-Hanger Foundation Distinguished Professor at MD Anderson. Vaccines specific to HPV antigens found on tumors had previously sparked a strong immune response, but had not, by themselves, been active against established cancers, Glisson said. "Vaccines are revving up the immune system, but the immunosuppressive tumor microenvironment probably prevents them from working," Glisson said. "Our thinking was that inhibition of PD-1 would address one mechanism of immunosuppression, empowering the vaccine-activated T lymphocytes to attack the cancer." The team combined the vaccine ISA101, which targets important peptides produced by the strongly cancer-promoting HPV16 genotype of the virus, along with nivolumab, a checkpoint inhibitor that blocks activation of PD-1 on T cells. Of the 24 patients with recurrent HPV16-related cancers, 22 had oropharyngeal (back of the throat) cancer, one had cervical cancer and one had anal cancer. Eight (33 percent) had a tumor response, two were complete. All eight had oropharyngeal cancer. Median duration of response was 10.3 months. [...]

2018-09-28T10:06:38-07:00September, 2018|Oral Cancer News|

OCF’s Tobacco Cessation Spokesperson and Bradley Cooper’s Stunt Double Rides in Pendleton

You won’t find Cody Kiser at this year’s NFR, but you will find him working as a stuntman in the 2014 blockerbuster hit “American Sniper” starring Bradley Cooper. The biographical war drama was directed by Clint Eastwood, and told the story of U.S. Navy Seal Chris Kyle. Kiser, who rode Saturn Rocket for a 75.5-point score Friday at the Pendleton Round-Up, stepped in for Bradley during the scene that shows Kyle riding broncs during his rodeo days before he joined the Navy. “That was the coolest thing I have ever done,” Kiser said. “I got to hang out for a day with Clint Eastwood and Bradley Cooper. Clint told me I looked a lot like Bradley. They said they wished they had me for the whole movie.” A friend of Kiser’s who does stunt work in California put Kiser in touch with the people from the movie. “They needed a bareback rider who had a certain look,” he said. “They had me and a saddle bronc rider, but he couldn’t ride bareback very well, so the job was mine.” Kiser, 27, said he was living in Texas near where Kyle was shot in 2013, and that he had a friend working at the Rough Creek Ranch-Lodge in Erath County, Texas, where Kyle was shot. “It’s such a small world,” he said. Kiser earned a nice paycheck for his work, but said playing Kyle, even in a stunt role, was an honor. “To be a part of that was unreal,” he [...]

2018-09-28T09:37:18-07:00September, 2018|OCF In The News|

New Book: Vaccines Have Always Had Haters

Date: 09/23/18 Source: National Public Radio Author: Susan Brink Vaccinations have saved millions, maybe billions, of lives, says Michael Kinch, associate vice chancellor and director of the Center for Research Innovation in Business at Washington University in St. Louis. Those routine shots every child is expected to get can fill parents with hope that they're protecting their children from serious diseases. But vaccines also inspire fear that something could go terribly wrong. That's why Kinch's new book is aptly named: Between Hope and Fear: A History of Vaccines and Human Immunity. He wrote it, he says, to present the science behind vaccines and to highlight the fallacy of anti-vaccine movements. NPR talked with Kinch about vaccines. This interview has been edited for clarity and length. The first attempts to control smallpox go back at least 1,000 years and didn't involve vaccines. Can you describe those attempts? Smallpox was probably killing a half a million people a year in Europe alone. The medical community had adopted a practice called nasal insufflation. You could take a little bit of the material from a smallpox scab, turn it into a powder and have a child snort it into the nose. Or you could intentionally scrape the skin and put material from a smallpox pustule under the skin of a healthy individual. That was called variolation. Those procedures caused smallpox, and people got sick. But far fewer of them died because most people would get a less virulent form of disease than if they [...]

2018-09-24T09:59:48-07:00September, 2018|Oral Cancer News|

Penn-led study raises hopes for vaccine to treat head and neck cancer

Date: 09/21/18 Source: The Inquire, philly.com Author: Marie McCullough The patient's head and neck cancer came roaring back, spreading to his lymph nodes and skin, which developed bleeding tumors. Yet despite a grim prognosis, that man is alive and cancer-free more than two years later. In a study led by the University of Pennsylvania and published Friday, researchers hypothesize that his remarkable remission is due to a promising combination: an experimental cancer vaccine that activated his disease-fighting T cells, plus Opdivo, one of the revolutionary "checkpoint inhibitor" drugs that cut a brake on the immune system. "Of course, I'm biased," said Charu Aggarwal, the Penn oncologist who led the study. "In my career, I haven't seen a vaccine as impactful as this." However, the remission may have been due to Opdivo alone; the study lacks data to rule out that possibility. Robert Ferris, director of the University of Pittsburgh Medical Center's Hillman Cancer Center and head of the pivotal study leading to approval of Opdivo, called the Penn-led study "an important intermediate step exploring a strategy that we hope will work." Conventional vaccines prevent diseases by priming the immune system to recognize the distinctive "antigens" on invading microbes. Therapeutic cancer vaccines, like the one in this study, are intended to work after cancer develops by provoking a heightened immune response. Despite decades of research, this approach remains experimental. The only approved product, the prostate cancer vaccine Provenge, was barely effective; the maker filed for bankruptcy in 2015. A major obstacle to treatment vaccines [...]

2018-09-24T09:42:13-07:00September, 2018|Oral Cancer News|

Youth vaping has soared in 2018, new data show

Source: www.wsj.com Authors: Betsy McKay and Jennifer Maloney Number of high schoolers who used e-cigarettes in the past 30 days has risen some 75% in 2018 Teen use of e-cigarettes has soared this year, according to new research conducted in 2018 that suggest fast-changing youth habits will pose a challenge for public-health officials, schools and parents. The number of high-school students who used e-cigarettes in the past 30 days has risen roughly 75% since last year, according to a person who has seen new preliminary federal data. That would equate to about three million, or about 20% of high-school students, up from 1.73 million, or 11.7% of high-school students in the most recently published federal numbers from 2017. Nearly a third of 13-to-18-year-olds who responded to a separate survey conducted by The Wall Street Journal with research firm Mercury Analytics said they currently vape. The new numbers offer a rare look at evolving teen vaping habits. Sales of e-cigarettes are expected nearly to double this year over 2017, and researchers have wondered how much of that increase is because of teen use. But there can be a long lag time between the collection of data and public reports. Most of the teens who vape said they are doing it for reasons other than to quit smoking, according to the Journal’s survey conducted in 49 states in May. More than half said they do it because they like the flavors that e-cigarette liquids come in and they think vaping is fun. [...]

2018-09-21T08:57:52-07:00September, 2018|Oral Cancer News|

RJR Slapped with $6.5M verdict over musician’s mouth cancer

Source: blog.cvn.com Author: Arlin Crisco R.J. Reynolds was hit with a $6.5 million verdict Tuesday for the part jurors found the company played in the mouth cancer a Florida musician developed after years of smoking. Harewood v. R.J. Reynolds, 2007-CA-46331. The award followed the Florida 11th Circuit Court jury’s conclusion that nicotine addiction and cigarettes caused the oral cancer doctors diagnosed Glenn Simmons with in 1995. Simmons, a bassist in bands throughout much of his life, began smoking as a teenager and smoked about a pack a day for decades. He died in 2003, at age 48, from complications related to cancer-related radiation therapy. Monday's verdict found Reynolds liable on fraud and conspiracy claims related to a sweeping scheme to hide the dangers of cigarettes. However, while jurors awarded Simmons' daughter, Hanifah Harewood $6.5 million in compensatory damages, they rejected a claim for punitives in the case. The case is one of thousands of Florida’s Engle progeny lawsuits against the nation’s tobacco companies. They stem from a 2006 Florida Supreme Court decision decertifying Engle v. Liggett Group Inc., a class-action tobacco suit originally filed in 1994. Although the state’s supreme court ruled that Engle progeny cases must be tried individually, it found plaintiffs could rely on certain jury findings in the original case, including the determination that tobacco companies had placed a dangerous, addictive product on the market and had conspired to hide the dangers of smoking through much of the 20th century. In order to be entitled to those [...]

2018-09-20T19:26:41-07:00September, 2018|Oral Cancer News|
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