US FDA approves Merck & Co's Gardasil: First cervical cancer vacc, potential blockbuster

The US Food and Drug Administration has approved Gardasil (quadrivalent human papillomavirus, types 6, 11, 16, 18, recombinant vaccine), the world's first vaccine against cervical cancer, a condition that affects about 10,000 women each year and kills an average of 10 every day.

The product is made by US drug major Merck & Co and is the first innoculation to offer protection from a cancer. The firm noted that it is approved for use in nine to 26-year old girls and women and is specifically indicated for the prevention of vulvar and vaginal precancers caused by HPV types 16 and 18, as well as the prevention of low-grade and precancerous lesions and genital warts.

Gardasil's approval is based on data from Phase I and III trials in 20,541 women aged 16 to 26 years, which demonstrated 100% prevention of cervical precancers and non-invasive cervical cancers, 95% prevention of low-grade cervical dysplasia (HPV 6, 11, 16 or 18) and 99% genital warts (HPV 6 or 11). Merck noted that there were no cases of cervical cancer in 8,487 women who received Gardasil compared to 53 events in 8,460 women on placebo.