publication date: Apr. 18, 2016
EU Approves Gardasil 9 Two-Dose Schedule
The European Commission approved a two-dose schedule for Gardasil 9, for adolescent girls and boys aged 9 to 14, in the 31 countries regulated by the European Medicines Agency.
This new schedule brings the label in line with recommendations in several European countries that opted for two-dose schedules in routine vaccination of adolescents in this age group, enabling Gardasil 9 to be considered in national vaccination programs.
Gardasil 9, a nine-valent Human Papillomavirus vaccine, has been licensed in Europe since June 2015 with a three-dose schedule for active immunization of individuals from the age of 9 years against cervical, vulvar, vaginal and anal cancers causally related to vaccine HPV types, and genital warts causally related to vaccine HPV types. It has been available in the United States since early 2015, with 7 million doses now distributed, according to Sanofi Pasteur MSD, the vaccine’s sponsor.
Gardasil 9 was approved in the U.S. under a three-dose regimen in December 2014.
Halaven (eribulin) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, to extend Halaven’s license to include patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease.
The opinion is based on phase III data demonstrating a median 7.2 month increase in overall survival compared to dacarbazine (15.6 months versus 8.4 months, HR = 0.511; 95% CI 0.346-0.753; P=0.0006) for people with unresectable advanced or metastatic liposarcomas.
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