Table 3.

Approved agents for treatment of precancerous lesions or cancer risk reduction—2012

AgentTargeted cohortIndication
Tamoxifen
  • Women with DCIS following breast surgery and radiation

Reduce the risk of invasive breast cancer
  • Women at high risk for breast cancer

Reduce the incidence of breast cancer
Raloxifene
  • Postmenopausal women at high risk for invasive breast cancer

Reduction in risk of invasive breast cancer
Cervarix
  • Females 9 through 25 years of age

Prevention of the following, caused by HPV types 16 and 18:
  • cervical cancer

  • cervical intraepithelial neoplasia grade 2 or worse and adenocarcinoma in situ

  • cervical intraepithelial neoplasia grade 1

GardasilGirls and women 9 through 26 years of agePrevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18; and the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
  • Cervical intraepithelial neoplasia grade 2/3 and cervical adenocarcinoma in situ

  • Cervical intraepithelial neoplasia grade 1

  • Vulvar intraepithelial neoplasia grade 2 and grade 3

  • Vaginal intraepithelial neoplasia grade 2 and grade 3

  • Anal intraepithelial neoplasia grades 1, 2, and 3

Boys and men 9 through 26 years of agePrevention of anal cancer caused by HPV types 16 and 18; and anal intraepithelial neoplasia grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18:
Photodynamic Therapy with PhotofrinMales and females with high-grade dysplasia in Barrett esophagus.Ablation of high-grade dysplasia in Barrett esophagus patients who do not undergo esophagectomy
CelecoxibaMales and females ≥18 years old with familial adenomatous polyposisReduction in the number of adenomatous colorectal polyps in FAP, as an adjunct o usual care (e.g., endoscopic surveillance, surgery)
Bacillus-Calmette- Guerin(BCG)Males and females with carcinoma in situ of the urinary bladderIntravesical use in the treatment and prophylaxis of carcinoma in situ of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection
ValrubicinMales and females with Bacillus- Calmette-Guerin–refractory carcinoma in situIntravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
FluorouracilMales and females with multiple actinic or solar keratosesTopical treatment of multiple actinic or solar keratoses
Diclofenac sodiumMales and females with actinic keratosesTopical treatment of actinic keratoses
Photodynamic Therapy with 5- aminolevulinic acidMales and females with actinic keratoses of the face or scalpTopical treatment of minimally to moderately thick actinic keratoses of the face or scalp.
MasoprocolbMales and females with actinic (solar) keratosesTopical treatment of actinic keratoses
Ingenol mebutateThose with actinic keratoses on the face, scalp, trunk and extremitiesTopical treatment of actinic keratoses
  • aFDA labeling voluntarily withdrawn by Pfizer, February 2011.

  • bWithdrawn from the U.S. market June 1996.