Friday, February 24, 2012

ACIP recommends routine HPV vaccination for 11- to 12-year-old boys

The CDC's Advisory Committee on Immunization Practices today approved routine recommendation in favor of administering the quadrivalent HPV vaccine for boys aged 11 to 12 years.
Committee members decided that the vaccine (Gardasil, Merck) was safe, efficacious and cost-effective enough to warrant routine usage in this population. The recommendation issued in 2009 was permissive, meaning providers could give the vaccine to boys, but it was not routinely administered. This change would put the HPV vaccine into the regular vaccination schedule. The three-vaccination series can start as early as age 9 years.
"The committee recommended that routine vaccination of males aged 11 or 12 years with three doses of quadrivalent vaccine be given to prevent HPV infection and HPV-related disease," Anne Schuchat, MD,director of the CDC's National Center for Immunization and Respiratory Diseases, said in a phone call with reporters. "Boys and young men 13 to 21 years of age who have not already received the vaccine should be vaccinated."
Anne Schuchat, MD
Anne Schuchat, MD
Insurance companies typically cover HPV vaccine in boys, but that is not necessarily the case for a permissive recommendation, according to Schuchat, who said a routine recommendation for a vaccine usually translates into coverage without co-pays.
The committee voted 8-5 with one abstention in favor of recommending vaccination for young men up to age 21 years with permissive recommendation for men aged 22 to 26 years. The committee considered recommending vaccination up to age 26 years, which would have harmonized recommendations for men and women, but concluded that the vaccine was not cost-effective in men aged older than 21 years.
According to the committee, in extending the quadrivalent vaccine to young men, the vaccine was 89% effective against genital warts and 75% effective against precancerous anal intraepithelial neoplasia. Schuchat said the number of girls receiving vaccinations has been disappointing, and there is hope that vaccinating boys will protect both young women and young men.


Tony Talebi, MD

Friday, February 17, 2012

Breast Cancer Drug Pertuzumab Gets FDA Priority Review

U.S. health regulators have granted a priority review for Roche Holding AG's (ROG.VX) experimental breast cancer drug pertuzumab, opening the way for a launch as early as 2012 for a product the Swiss company hopes can contain damage from lost sales when top seller Herceptin loses patent protection in a few years' time.
The U.S. Food and Drug Administration gave priority review status to the medicine, a humanized monoclonal antibody, after clinical trials using breast cancer patients showed it added six months to the time before their disease worsened. Breast cancer is the most common cancer among women worldwide.
Patients in the Phase III CLEOPATRA study who received pertuzumab in combination with Herceptin - another Roche breast cancer drug - and a chemotherapy agent called docetaxel lived for an average of 18.5 months without their tumors growing. That compared with 12.4 months for those who got only Herceptin and docetaxel.
People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death.

This new Anti-Her therapy coupled with mTOR inhibitors are both very promising news for breast cancer patients.

Tony Talebi, MD

Saturday, February 11, 2012

FDA approves first drug for metastatic basal cell carcinoma

The FDA today approved vismodegib for the treatment of adults with basal cell carcinoma.
The FDA approval, granted under the agency’s priority review program, allows vismodegib (Erivedge, Genentech) to be used by adults with locally advanced basal cell carcinoma who cannot be treated with radiation or surgery, or those whose disease has spread to other parts of the body.
Vismodegib is the first FDA-approved drug for metastatic basal cell carcinoma, the most common form of skin cancer. Vismodegib — taken once a day — inhibits the Hedgehog pathway, which is active in most basal cell cancers.
“Our understanding of molecular pathways involved in cancer, such as the hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”

This is a very large milestone in the treatment of this very common malignancy.

Tony Talebi, MD