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【drug-news】美国批准Gardasil疫苗用于预防肛门癌
BY ALICIA AULT 2010-12-22
Elsevier Global Medical News
Breaking News
The U.S. Food and Drug Administration on Dec. 22 approved the Gardasil vaccine to prevent anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people aged 9-26 years.
The approval was expected, as in November, an FDA advisory committee agreed that the data submitted by Merck & Co. supported approval. Merck had filed for the additional approval in early 2010.
“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Anal cancer is not common, affecting 5,300 people annually in the United States, according to estimates from the American Cancer Society. But HPV is associated with approximately 90% of anal cancer, according to the FDA.
The vaccine was approved based on data from a randomized, controlled trial of 602 men who have sex with men (MSM), a group known to be at the greatest risk for anal cancer. Those data were part of a larger study that led to Gardasil’s approval in 2009 for preventing genital warts in boys and men. The participants received three doses of vaccine or a placebo. Compared with placebo, the vaccine showed 78% effectiveness in preventing anal intraepithelial neoplasms – precursors to anal cancer – related to HPV types 6, 11, 16, and 18.
According to the FDA, because anal cancer is the same in both men and women, the effectiveness data could support approval in both sexes. The agency stressed that for all indications, the vaccine is most effective when given prior to infection.
The new approval could be cause for the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to revisit a previous recommendation against routine HPV vaccination for boys and men for genital wart prevention. The ACIP meets in February.
Gardasil is approved in 121 countries and, according to Merck, since its first approval in 2006 through May 31, 2010, more than 65 million doses have been distributed worldwide. It is approved in the U.S. for use in girls and young women aged 9-26 years for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
Copyright 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Subjects:
general_primary, oncology, OncologyEX, womans_health, infectious, pediatrics, dermatology, general_primary, Pediatrics
美国批准Gardasil疫苗用于预防肛门癌
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12月22日，美国食品药品管理局(FDA)批准Gardasil疫苗在9~26岁人群中用于预防人乳头瘤病毒(HPV) 6、11、16和18型引起的肛门癌和相关癌前病变。
该疫苗此次获批是基于一项随机对照研究的结果。该研究入选602名男同性恋者(男同性恋者发生肛门癌的风险被认为是最高的)。受试者接种3个剂次的疫苗或安慰剂。与安慰剂相比，该疫苗在预防HPV 6型、11型、16型和18型相关肛门上皮内肿瘤(肛门癌前病变)方面的有效率为78%。FDA表示，由于肛门癌无性别差异，因此上述有效率数据支持批准该疫苗同时应用于男性和女性。FDA强调，对于所有适应证，该疫苗在感染前接种是最有效的。
据来自Gardasil生产商默沙东的资料，自2006年首次获批至2010年5月31日，该疫苗已在121个国家获得批准，已有超过6500万剂分布在世界各地。在美国，该疫苗获准用于9~26岁的青少年和年轻成人女性预防HPV 16型和18型引起的宫颈癌、外阴癌和阴道癌；HPV 6型和11型引起的生殖器疣（尖锐湿疣）；HPV 6型、11型、16型和18型引起的癌前病变或增生性病变。2009年，Gardasil也已获准用于青少年和成人男性预防生殖器疣，但美国疾病预防控制中心(CDC)的免疫接种咨询委员会(ACIP) 不建议将HPV疫苗常规用于青少年和成人男性预防生殖器疣。此次的新批准可能会促使ACIP重新考虑这一建议。
FDA生物制品评价和研究中心主任Karen Midthun 博士表示，通过接种Gardasil疫苗来预防肛门癌可降低该病发生的可能性，并可避免随后的手术、放疗或化疗，因此具有重要意义。
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作者:admin@医学,生命科学 2010-12-27 13:02
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