You are here

FDA Agrees to Review 9-Valent HPV Vaccine

Vaccinations prevent precancers in phase III study (February 20)

The biologics license application (BLA) for V503, an investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the FDA.

In November 2013, the vaccine’s developer (Merck) announced that vaccination with V503 had prevented approximately 97% of cervical, vaginal, and vulvar precancers caused by HPV types 31, 33, 45, 52, and 58 in a pivotal phase III efficacy study. V503 also generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by Merck’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, and 18] vaccine, recombinant).

V503 includes five more HPV types (31, 33, 45, 52, and 58) in addition to the four HPV types (6, 11, 16, and 18) in Gardasil.

Sources: Merck; February 20, 2014; and Merck; November 4, 2013.

Recent Headlines

Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs