Table 3.

Approved Agents for Treatment of Precancerous Lesions or Cancer Risk Reduction - 2012

Agent	Targeted Cohort	Indication
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 (CIN) grade 2 or worse and adenocarcinoma in situ cervical intraepithelial neoplasia (CIN) grade 1
Gardasil	Girls and women 9 through 26 years of age	Prevention 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 (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
	Boys and men 9 through 26 years of age	Prevention of anal cancer caused by HPV types 16 and 18; and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18:
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 o 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
Ingenol mebutate	Those with actinic keratoses on the face, scalp, trunk and extremities	Topical treatment of actinic keratoses

^*FDA labeling voluntarily withdrawn by Pfizer, February 2011

^**Withdrawn from US Market June 1996