Committee Recommends HPV Vaccine Approval
The agency's Vaccines and Related Biological Products Advisory Committee unanimously agreed that data from phase II and III clinical trials conducted in the United States, Europe, and South America - which included more than 20,000 participants - supported that the vaccine is safe and effective in preventing HPV-related cervical cancer as well as precancerous cervical, vaginal, and vulvular lesions.
The committee's chair, Dr. Monica Farley, stressed that, if the FDA approves the vaccine, postmarket studies of Gardasil to ensure its long-term effectiveness and safety would be very important.
Merck submitted a Biologics License Application to the FDA for the marketing approval of Gardasil last December, and the agency has said it will make a decision on the application by June 8. Gardasil and another HPV vaccine manufactured by GlaxoSmithKline were developed on the basis of work originally done by NCI investigators.
Although Merck has only conducted clinical trials to test the vaccine's effectiveness in women 16-26 years old, it requested approval for use in females ages 9-26. Logistical and ethical concerns have precluded the company from conducting efficacy trials in girls 9-15, so the company instead conducted immunogenicity trials in girls of this age to measure their immune response to the vaccine.
Younger females had an even stronger immune response than the older females in the efficacy trials, explained Dr. Eliav Barr of Merck. The advisory committee unanimously agreed that these data supported "bridging" or extending the effectiveness data to include this younger group.
Several committee members commented that, if Gardasil does come to market, it will be very important to stress it's not a substitute for cervical cancer screening.
New Smoking Cessation Medication Approved
Chantix is approved for use in adults and is taken for 12 weeks; patients who successfully quit may take an additional 12 weeks of the medication to increase their likelihood of long-term cessation. The data that led to the approval of Chantix came from 6 clinical trials including more than 3,600 patients; 5 of the 6 studies were randomized controlled clinical trials in which Chantix was shown to be superior to placebo. All the trials provided patients with educational materials on smoking cessation and up to 10 minutes of counseling at each weekly treatment visit.
About 1 in every 5 adult Americans (44.5 million) smokes cigarettes, and each year, more than 440,000 Americans die prematurely from illnesses caused by tobacco use. "FDA's approval of Chantix provides an additional option for people who smoke to quit," said Dr. Glen Morgan of NCI's Tobacco Control Research Branch. "NCI recommends that smokers employ behavioral techniques with every quit attempt." Information and assistance with smoking cessation can be found at www.smokefree.gov or by calling 1-800-QUIT-NOW.