Skip to main content
. Author manuscript; available in PMC: 2016 Apr 4.
Published in final edited form as: CA Cancer J Clin. 2015 Aug 18;65(5):345–383. doi: 10.3322/caac.21287

Table 1.

FDA Approved Agents for Treatment of Precancerous Lesions or Cancer Risk Reduction in Indicated Cohorts

Agent Targeted Cohort in Indication* FDA Indication*
Tamoxifen Women with DCIS following breast surgery and radiation Reduction in risk of invasive breast cancer
Tamoxifen 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) Reduction in 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 carcinoma in situ 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
HPV Vaccine (Cervarix) Females 9 through 25 years of age Prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18:

  • Cervical cancer

  • Cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ

  • Cervical intraepithelial neoplasia (CIN) grade 1
HPV Vaccine (Gardasil 9) Girls and women 9 through 26 years of age Prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

  • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, & 58

  • Genital warts caused by HPV types 6 and 11


And the following precancerous or dysplastic lesions caused by HPV types 6,11, 16, 18, 31, 33, 45, 52, and 58:

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS)

  • Cervical intraepithelial neoplasia (CIN) grade 1

  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
HPV Vaccine (Gardasil 9) Boys and men 9 through 15 years of age 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, & 58

  • Genital warts caused by HPV types 6 and 11


And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, & 58:

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
Photodynamic Therapy (PDT) with Photofrin Males and females with high-grade dysplasia in Barrett’s esophagus Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy
Celecoxib** Males and females ≥18 years old with familial adenomatous polyposis (FAP) Reduction in the number of adenomatous colorectal polyps in FAP, as an adjunct to usual care (e.g., endoscopic surveillance, surgery)
Bacillus-Calmette-Guerin(BCG) Males and females with carcinoma in situ (CIS) of the urinary bladder Intravesical use in the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR)
Valrubicin Males and females with Bacillus-Calmette-Guerin(BCG)-refractory carcinoma in situ (CIS) Intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality
Fluorouracil Males and females with multiple actinic or solar keratoses Topical treatment of multiple actinic or solar keratoses
Diclofenac sodium Males and females with actinic keratoses Topical treatment of actinic keratoses
Photodynamic Therapy (PDT) with 5-aminolevulinic acid Males and females with actinic keratoses of the face or scalp Topical treatment of minimally to moderately thick actinic keratoses of the face or scalp.
Masoprocol*** Males and females with actinic (solar) keratoses Topical treatment of actinic keratoses
Imiquimod Immunocompetent adults Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp
Ingenol mebutate Males and females with actinic keratoses on the face, scalp, trunk and extremities Topical treatment of actinic keratoses
*

According to FDA product label

**

FDA labeling voluntarily withdrawn by Pfizer, February 2011

***

Withdrawn from US market, June 1996