Merck

HPV vaccine fails to get nod for routine use in boys

Source: Medscape.com Author: Robert Lowes October 21, 2009 — Despite hearing impassioned pleas to protect both men and women from cancer, a federal advisory panel today declined to recommend that a human papillomavirus (HPV) vaccine be routinely administered to boys to prevent genital warts. Instead, the Advisory Committee on Immunization Practices (ACIP) issued a "permissive" recommendation stating that physicians have the option of vaccinating boys with the HPV vaccine Gardasil(Merck) for genital-wart protection. ACIP noted that boys should receive the vaccine "before exposure to HPV through sexual contact." In 2006, the US Food and Drug Administration (FDA) approved Gardasil for use in girls and young women to prevent cervical and other cancers as well as precancers caused by HPV types 16 and 18. Last week, the FDA also approved Gardasil for use in males aged 9 through 26 to prevent genital warts. In making its recommendation today, ACIP appeared to be swayed in part by published research questioning the cost-effectiveness of routine vaccination of boys with Gardasil. The committee's decision has far-reaching economic effects because third-party payers typically pay for vaccinations that are recommended for routine use, but not those coming with a permissive recommendation. More at Stake Than Genital Wart Prevention Proponents of routine vaccination of boys with Gardasil told the committee Wednesday during the public comment period that more was at stake than merely preventing genital warts. They underlined the need to also prevent oral, throat, penile, and anal cancers caused by HPV. David Hastings, a spokesperson for the [...]

Charlotte Parker2009-10-26T09:22:06-07:00October, 2009|OCF In The News, Oral Cancer News|

37% of U.S. teen girls got HPV vaccine

Source: www.medscape.com Author: Daniel J. DeNoon More than one in three U.S. teen girls has had at least one shot of Gardasil, a CDC survey shows, but only 18% of girls got the three shots needed for protection. The survey includes girls vaccinated through 2008, two years after Gardasil's approval. A second HPV vaccine, GlaxoSmithKline's Cervarix, is expected to be approved this year. Gardasil, from Merck, protects against the four strains of the sexually transmitted human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts. But other HPV strains also cause these diseases, so even vaccinated women still need regular Pap exams. Gardasil's acceptance varied widely by state. More than half of all teen girls aged 13 to 17 had at least one shot of the HPV vaccine in six states: Arizona, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont. Fewer than one in five girls got the vaccine in three states: Georgia, Mississippi, and South Carolina. Coverage was highest in Rhode Island (54.7%) and New Hampshire (54.4%) and lowest in Mississippi (15.8%) and Georgia (18.5%). Cervical cancer is more common in women of Hispanic descent and in people living below the poverty level. Perhaps because the Vaccines for Children (VFC) program provides the expensive vaccine to uninsured children, girls in these groups had higher rates of coverage than other girls. The CDC reported results of the survey in today's issue of Morbidity and Mortality Weekly Report. Source: MMWR, Sept. 17, 2009; vol 58: pp 997-1001.

Oral Cancer Foundation News Team - A2009-09-25T12:57:21-07:00September, 2009|Oral Cancer News|

Initial COIN study results presented at European Oncology Congress

Source: Drugs.com Author: Staff • Results inconsistent with data from all Erbitux pivotal studies • Further analyses planned by the Medical Research Council that conducted the independent COIN study Berlin/Darmstadt, Germany, September 23, 2009 – The Medical Research Council (MRC), a UK-based, publicly-funded organization dedicated to improving human health, today presented the initial results of the independent Phase III COINa study, which did not meet its primary endpoint of overall survival (OS).1 These findings were presented today at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany. The COIN study was designed to evaluate whether the addition of Erbitux® (cetuximab) to one of two oxaliplatin-based chemotherapy regimens significantly improved outcomes in previously untreated metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors. The median OS was not statistically significant at 17.0 months in the Erbitux treatment arm compared to 17.9 months for the chemotherapy-alone group (hazard ratio [HR] 1.038; p=0.68).1 “Imbalances in the chemotherapy administered between the different study arms were reported previously in the interim safety analysis,” explained Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “Further analysis of the dose intensity and 2nd-line treatment, and other factors, such as the advanced disease of patients in the study, are ongoing to determine why the COIN results are not aligned with existing evidence from the other randomized, 1st-line studies, including the significant increase in overall survival achieved with the CRYSTAL study.” Results [...]

Charlotte Parker2009-09-24T16:48:29-07:00September, 2009|Oral Cancer News|

Drugmaker Merck seeks Gardasil approval for boys

Source: www.forbes.com Author: Linda A. Johnson Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers. The application was submitted in late December, Merck spokeswoman Amy Rose said Tuesday. It was long planned as part of Whitehouse Station, N.J.-based Merck's strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs. Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance. However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen. Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s. The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more. The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine. The agency approved use of Gardasil in females ages 9 [...]

Oral Cancer Foundation News Team - A2009-01-07T07:17:35-07:00January, 2009|Oral Cancer News|