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|

European Commission amends licence for Cervarix

Source: www.pharmpro.com Author: press release GlaxoSmithKline (GSK) confirmed today that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix®. The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. The licence amendment is supported by data from the largest efficacy trial of a cervical cancer vaccine conducted to date, the PATRICIA study, and acknowledges that Cervarix® has shown efficacy beyond HPV 16 and 18, the two virus types contained in the vaccine. The summary of product characteristics (SPC) for Cervarix® will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of the human papillomavirus (HPV) and will reflect data showing efficacy against the two vaccine types contained in the vaccine (HPV 16 and 18) and the three next most common cancer-causing virus types (HPV 31, 33 and 45).* Together these five HPV types (16, 18, 31, 33 and 45) account for 80 percent of all cervical cancers. Note: 1. Vaccine efficacy is different for each of the HPV types 16, 18, 31, 33 and 45, and varies in different cohorts and endpoints.

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|

HPV-associated base of tongue squamous cell carcinoma incidence increasing in Sweden

Source: www.hemonctoday.com Author: staff The incidence for base of tongue squamous cell carcinoma increased significantly in Sweden between 1998 and 2007, and by 2007, more than 80% of these cases were HPV-positive. Various studies during the past 20 years have indicated that HPV is a risk factor for oropharyngeal cancer. However, few studies have assessed the specific sub-sites of the oropharynx. In this study, researchers assessed the increased incidence of base of tongue cancer and the association of HPV in 109 patients diagnosed with base of tongue cancer between 1998 and 2007 in Stockholm, Sweden. The researchers obtained diagnostic pretreatment paraffin-embedded tumor biopsies from 95 patients. DNA samples were obtained from 30-mcm paraffin-embedded base of tongue biopsy slices. Age at diagnosis ranged from 41 to 85 years. From 1970 to 2007, the age-standardized incidence of base of tongue squamous cell carcinoma increased from 0.15 per 100,000 person-years between 1970 and 1974 to 0.47 per 100,000 person-years between 2005 and 2007. HPV DNA was found in 75% of base of tongue cancer cases during this time. Of the HPV-positive tumors, 86% were HPV-16–positive and seven were HPV-33–positive. During the study period, the incidence of HPV-positive base of tongue cancers persistently increased (see chart). A significant increase was found in the proportion of HPV-positive cancer between 1998 and 2001 compared with 2004 and 2007 (58% vs. 84%; P<.05). When compared with patients with HPV-negative tumors, patients with HPV-positive tumors were likely to be stage IV (P<.02) and had less advanced T-stage (P<.05 [...]

2010-02-05T22:20:41-07:00February, 2010|Oral Cancer News|
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