BRIEF—Added Chinese approval for GSK's Cervarix

UK pharma major GlaxoSmithKline (GSK) today announced that China’s National Medical Products Administration (NMPA) has approved a two-dose vaccine schedule for Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, in girls aged between nine to 14 years for the prevention of cervical cancer, cervical intraepithelial neoplasia and adenocarcinoma in situ causally related to oncogenic Human Papillomavirus (HPV) types 16 and 18.

The NMPA authorization of the two-dose regimen adds China to two-dose approvals in approximately 100 countries, including the European Union, Asia, Africa, and Latin America. The three-dose schedule remains on the label for girls and women aged 15-45 years in China.

Cervical cancer in China

Cervical cancer has the highest mortality of all malignant tumors in the female reproductive system in China, with 110,000 new cases of cervical cancer and 59,000 deaths due to the disease. Incidence and mortality rates show an increasing trend in younger women. The potential impact of vaccines against oncogenic HPV types 16 and 18 is estimated to be high (84.5%) against total squamous cell carcinoma (SCC).