FDA Approves Cervarix for Cervical Cancer Prevention
FDA Approves Cervarix for Cervical Cancer Prevention
The US Food and Drug Administration has approved a bivalent [recombinant] human papillomavirus (HPV) vaccine (Cervarix, GlaxoSmithKline) for the prevention of cervical cancer and precancers caused by HPV types 16 and 18 in women aged 10 through 25 years.
“Immunization with a vaccine such as Cervarix — along with annual doctor visits and Pap tests — will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties,” said Deirdre Connelly, president, North American Pharmaceuticals, GlaxoSmithKline, in a company news release.
In clinical studies, the vaccine demonstrated a 93% efficacy rate for preventing cervical precancer (cervical epithelial neoplasia grade ≥ 2 lesions and adenocarcinoma in situ) and cancer associated with HPV types 16 and 18, which are responsible for approximately 75% of cervical cancers in North America.
Study results also showed that the vaccine prevented 70% of precancerous lesions, regardless of HPV type; further analysis revealed an approximately 89% efficacy rate against lesions caused by HPV type 31, the third most common cancer-causing type in North America.
The recommended vaccination regimen for the drug consists of a 0.5-mL dose administered intramuscularly at baseline, 1, and 6 months. Because of the risk for syncope, those receiving the vaccine should be observed for 15 minutes after each dose.
Adverse events most commonly reported in more than 20% of study patients included injection site reactions (pain, erythema, and swelling), fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
The bivalent HPV vaccine previously was approved for use in the European Union, Australia, Brazil, South Korea, Mexico, and Taiwan.
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