Table 2.

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

Agent	Targeted cohort	indication
Tamoxifen	• Women with DCIS following breast surgery and radiation • 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 risk of invasive breast cancer 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 age	The 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 9	Girls and women 9 through 26 years of age	The 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 age	The 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 Photofrin	Males and females with high-grade dysplasia in BE	Ablation of HGD in patients with BE who do not undergo esophagectomy
Celecoxiba	Males and females >18 years old with FAP	Reduction in the number of adenomatous colorectal polyps in FAP, as an adjunct of usual care (e.g., endoscopic surveillance, surgery)
BCG	Males and females with CIS of the urinary bladder	Intravesical 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
Valrubicin	Males and females with BCG-refractory CIS	Intravesical therapy of BCG-refractory 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 keratosis	Topical treatment of multiple actinic or solar keratosis
Diclofenac sodium	Males and females with actinic keratosis	Topical treatment of actinic keratosis
PDT with 5- aminolevulinic acid	Males and females with actinic keratosis of the face or scalp	Topical treatment of minimally to moderately thick actinic keratosis of the face or scalp
Masoprocolb	Males and females with actinic (solar) keratosis	Topical treatment of actinic keratosis
Imiquimod	Immunocompetent adults	Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, actinic keratosis on the face or scalp
Ingenol mebutate	Males and females with actinic keratosis on the face, scalp, trunk and extremities	Topical 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..