Table 2.

Approved agents for the treatment of precancerous lesions or cancer risk reduction

AgentTargeted cohortIndication
Tamoxifen•Women with DCIS following breast surgery and radiationReduce the risk of invasive breast cancer
• Women at high risk for breast cancer (“high risk” defined as women at least 35 years of age with a 5-year predicted risk of breast cancer >/= 1.67%, as calculated by the Gail Model)Reduce the incidence of breast cancer
Raloxifene• Postmenopausal women at high risk for invasive breast cancer (“high risk” defined as at least one breast biopsy showing lobular CIS or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >/= 1.66% (based on the modified Gail model).Reduction in risk of invasive breast cancer (Note: Raloxifene does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene)
Cervarix• Females 9 through 25 years of ageThe prevention of the following diseases caused by oncogenic HPV types 16 and 18:
• Cervical cancer
• CIN grade 2 or worse and adenocarcinoma in situ
• CIN grade 1
Gardasil 9Girls and women 9 through 26 years of ageThe prevention of the following diseases caused by HPV types included in the vaccine:
• Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
• CIN grade 2/3 and cervical AIS
• CIN grade 1
• VIN grade 2 and grade 3
• VaIN grade 2 and grade 3
• AIN grades 1, 2, and 3
Boys and men 9 through 26 years of ageThe prevention of the following diseases caused by HPV types included in the vaccine:
• Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
• AIN grades 1, 2, and 3
PDT with PhotofrinMales and females with high-grade dysplasia in BEAblation of HGD in patients with BE who do not undergo esophagectomy
CelecoxibaMales and females >18 years old with FAPReduction in the number of adenomatous colorectal polyps in FAP, as an adjunct of usual care (e.g., endoscopic surveillance, surgery)
BCGMales and females with CIS of the urinary bladderIntravesical use in the treatment and prophylaxis of CIS of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following TUR
ValrubicinMales and females with BCG-refractory CISIntravesical therapy of BCG-refractory CIS 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 keratosisTopical treatment of multiple actinic or solar keratosis
Diclofenac sodiumMales and females with actinic keratosisTopical treatment of actinic keratosis
PDT with 5-aminolevulinic acidMales and females with actinic keratosis of the face or scalpTopical treatment of minimally to moderately thick actinic keratosis of the face or scalp
MasoprocolbMales and females with actinic (solar) keratosisTopical treatment of actinic keratosis
ImiquimodImmunocompetent adultsTopical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, actinic keratosis on the face or scalp
Ingenol mebutateMales and females with actinic keratosis on the face, scalp, trunk and extremitiesTopical treatment of actinic keratosis
  • Abbreviations: AIN, anal intraepithelial neoplasia; AIS, adenocarcinoma in situ; BE, Barrett's esophagus; BCG, Bacillus-Calmette-Guerin; CIN, cervical intraepithelial neoplasia; CIS, carcinoma in situ; DCIS, ductal carcinoma in situ; FAP, familial adenomatous polyposis; HGD, high-grade dysplasia; HPV, human papillomavirus; PDT, photodynamic therapy; VaIN, vaginal intraepithelial neoplasia; TUR, transurethral resection; VIN, vulvar intraepithelial neoplasia.

  • aFDA labeling voluntarily withdrawn by Pfizer, February 2011.

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