Expanded age indication cleared for Gardasil 9 in males

Source: www.FormularyJournal.ModernMedicine.comAuthor: Erin Bastick FDA approved an expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males. Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52, and 58) cause approximately 90% to 95% of HPV-related anal cancers, 90% of cervical cancers, and 80% of high-grade cervical lesions worldwide.These 7 types also cause the majority of HPV-related vulvar and vaginal cancers. Gardasil 9 includes the greatest number of HPV (Human Papillomavirus) types of any available HPV vaccine. Gardasil 9 was previously approved for use in girls and young women aged 9 to 26 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 22, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. As for use in male patients, the vaccine was previously approved for use in boys aged 9 to 15 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. With the newest approval, Gardasil 9 is now also indicated for use in males aged 16 to 26 years for the prevention of these diseases. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage in [...]

2015-12-30T18:31:17-07:00December, 2015|Oral Cancer News|

Quadrivalent HPV vaccine may be effective in young men

Source: www.medscape.org Author: Laurie Barclay, MD; Charles P. Vega, MD Quadrivalent human papillomavirus (HPV) vaccine may prevent infection with HPV types 6, 11, 16, and 18 and the development of related external genital lesions in young men 16 to 26 years old, according to the results of a randomized, placebo-controlled, double-blind trial reported in the February 3 issue of the New England Journal of Medicine. "Infection with ...HPV and diseases caused by HPV are common in boys and men," write Anna R. Giuliano, PhD, from the Risk Assessment, Detection, and Intervention Program, H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, and colleagues. "We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men." The study sample consisted of 4065 healthy boys and men, aged 16 to 26 years, enrolled from 18 countries. The primary efficacy goal was to demonstrate that use of the quadrivalent HPV vaccine was associated with a lower incidence of external genital lesions related to HPV-6, 11, 16, or 18. The investigators used a per-protocol population, in which participants received all 3 vaccinations and had tested negative for relevant HPV types at enrollment, and an intent-to-treat population, in which participants received vaccine or placebo, regardless of baseline HPV status. In the intent-to-treat population, there were 36 external genital lesions in the vaccine group and 89 in the [...]

2011-02-15T13:47:01-07:00February, 2011|Oral Cancer News|

Oral sex can add to risk of HPV positive cancers

Source: www.time.com Author: Coco Masters Oral sex can get most men's attention. The topic becomes considerably more relevant, however, when coupled with a new study linking the human papillomavirus (HPV) to an increased risk of a kind of oral cancer more often seen in men. The study, which appears in this week's New England Journal of Medicine (NEJM), shows that men and women who reported having six or more oral-sex partners during their lifetime had a nearly ninefold increased risk of developing cancer of the tonsils or at the base of the tongue. Of the 300 study participants, those infected with HPV were also 32 times more likely to develop this type of oral cancer than those who did not have the virus. These findings dwarf the increased risk of developing this so-called oropharyngeal cancer associated with the two major risk factors: smoking (3 times greater) or drinking (2.5 times greater). HPV infection drives cancerous growth, as it is widely understood to do in the cervix. But unlike cervical cancer, this type of oral cancer is more prevalent in men. HPV is ubiquitous. Of the 120 strains isolated from humans — about 40 of which are in the mouth and genital tracts — Merck's recently FDA-approved vaccine, Gardasil, protects against four: HPV-6 and HPV-11, which cause warts; and HPV-16 and HPV-18, which cause about 70% of cervical cancers. Similarly, according to the study, HPV-16 was present in 72 of the 100 cancer patients enrolled in the study. Between 12,000 and [...]

New vaccine against HPV approved in Canada

Source: www.ctv.ca Author: staff Canadian women have a choice of two vaccines against HPV, the family of viruses that can cause cervical cancer, now that Health Canada has approved GlaxoSmithKline's vaccine, Cervarix. The vaccine, which is expected to be available by the end of the month, will compete against Gardasil, a product of Merck Canada, which has been on the Canadian market since 2006. Cervarix has been available in Europe since 2007, and was approved in the U.S. this past fall. Health Canada said its approval was based on a review of clinical trials on nearly 30,000 women. The competing vaccines will be similarly priced, at about $400. Each vaccine requires three doses and are meant for girls and women aged 10 to 25, ideally before they become sexually active. While there are differences between the two vaccines, each offers good protection against infection with the most dangerous strains of HPV, the Society of Gynecologic Oncology of Canada (GOC) said in a statement Tuesday. The GOC added that each vaccine has had an excellent safety profile both in pre-market testing and after extensive use worldwide. Cervarix is designed to protect against two human papillomavirus strains: HPV 16 and 18. Those strains are responsible for more than 70 per cent of cases of cervical cancer. It also offers some protection against three other cancer-causing strains HPV 31, 33 and 45. Between them, the four strains account for more than 80 per cent of cervical cancer cases. Gardasil also prevents infection with [...]

2010-02-11T09:55:32-07:00February, 2010|Oral Cancer News|

Vaccines plus screening could end cervical cancer

Source: www.cancernetwork.com Author: Fram Lowry Out with the old and in with the new is a commonly followed maxim in medicine given the rapid pace of developments in diagnosis and treatment. Human papillomavirus vaccines are relative newcomers to the cervical cancer armamentarium, but they cannot be relied on to do the job on their own; screening is still a must. Richard B. Roden, PhD, from Johns Hopkins University in Baltimore, and Carlos L. Santos, MD, from the Instituto Nacional de Enfermedades Neoplasicas in Lima, Peru, discussed the merits and drawbacks of HPV vaccines and standard screening during a session on female malignancies at ASCO 2009 in Orlando Long-term protection The widespread vaccination of adolescents against HPV will be critical to the eradication of cervical cancer, said Dr. Roden, an associate professor in the department of pathology. “HPV virus-like particle [VLP] vaccines are very effective in preventing genital HPV infection and neoplastic disease,” he explained. “Solid protection has been observed for more than six years after vaccination, suggesting vaccine protection is likely to be long-term, although the need for a booster is not out of the question.” To date, two HPV vaccines are FDA-approved: Gardasil from Merck, produced in yeast, and Cervarix from GlaxoSmithKline, produced in insect cells. In October 2009, Gardasil was approved by the FDA for use in boys and men (aged 9-26) for the prevention of genital warts caused by HPV-6 and HPV-11. Both vaccines target HPV-16 and HPV-18, the two most common oncogenic HPV types. Gardasil also [...]

2009-12-30T13:16:35-07:00December, 2009|Oral Cancer News|
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