GlaxoSmithKline has finally received approval from regulators in the USA to market its cervical cancer vaccine Cervarix.

The US Food and Drug Administration has given the green light to Cervarix for the prevention of cervical pre-cancers and cervical cancer associated with human papillomavirus types 16 and 18 for use in girls and young women, aged 10-25. The approval was based on data from clinical trials in more than 30 countries involving nearly 30,000 females and the jab is expected to be commercially available in the USA before the end of the year.

The news comes just a month after the FDA told GSK that a decision to approve the cervical cancer vaccine had once again been put back. That frustrated the company, seeing as how earlier in September the agency’s Vaccines and Related Biological Products Advisory Committee had voted that clinical data support both the efficacy and safety of Cervarix (12-1 and 11-1, respectively). That was after GSK had satisfied requests contained in a complete response letter issued in 2007 requesting more data.

Cervarix can now compete against Merck & Co’s well-established jab Gardasil, which has been on the market in the USA since 2006. The American Cancer Society estimates that in 2009, in the USA, 11,000 women will be diagnosed with the disease and 4,000 will die.

Jab approved in Japan as well
Meantime, the Japanese Ministry of Health, Labour and Welfare has approved Cervarix, which is formulated with the firm’s AS04 adjuvant, in girls and women aged 10 and above. The file included an interim analysis of the largest efficacy trial of a cervical cancer vaccine, GSK noted, which involved nearly 19,000 women, a third of which were from Asia.

Marc Dunoyer, president of GSK Japan, said that the firm is committed to working alongside the Japanese government “to help ensure that women and girls are educated about the role that vaccination can play in protecting them against it”. Cervical cancer currently kills an estimated 3,500 Japanese women each year and the company noted that research has shown that incidence of the disease is on the increase, particularly amongst women in their 20s and 30s “where it is now the leading cause of cancer in the country”.

The US and Japanese approvals mean that 100 licences have been obtained for Cervarix