Table 1 Cancer chemoprevention agents approved by FDA
From: Cancer chemoprevention: signaling pathways and strategic approaches
Cancer type | Agent and date first approveda | Property | Mechanism of action | Targeted cohort in indication | Reference |
|---|---|---|---|---|---|
Breast cancer | Tamoxifen (1998) | Synthetic agent | Endocrine therapy | Reduce the incidence of breast cancer in (pre- and postmenopausal) women at high risk; reduce the risk of invasive breast cancer in women with ductal carcinoma in situ after breast surgery and radiation. | |
Breast cancer | Raloxifene (2007) | Synthetic agent | Endocrine therapy | Reduce the risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. | |
Skin cancer | Fluorouracil cream (1970) | Synthetic agent | Topical chemotherapy | Topical treatment of multiple actinic keratosis (AK). | |
Skin cancer | Photodynamic therapy (PDT) with 5-aminolevulinic acid (1999) | Synthetic agent | Combination therapy | Topical treatment of minimally to moderately thick AK of face or scalp. | |
Skin cancer | Diclofenac gel (2000) | Synthetic agent | Topical non-steroidal anti-inflammatory drug | Topical treatment of AK. | |
Skin cancer | Imiquimod cream (2004) | Synthetic agent | Immune modulator | Topical treatment of nonhyperkeratotic, nonhypertrophic AK of the face or scalp. | |
Skin cancer | Ingenol mebutate gel (2012) | Natural compound | Topical chemotherapy | Topical treatment of AK. | |
Skin cancer | Tirbanibulin (2020) | Synthetic agent | Microtubule inhibitor | Topical treatment of AK of face or scalp. | |
Bladder cancer | Bacillus Calmette-Guerin (BCG, 1990) | Biological product | Immunotherapy | Intravesical use for the prevention of carcinoma in situ of bladder and primary or recurrent stage Ta and/or T1 papillary tumors after transurethral resection. | |
Bladder cancer | Valrubicin (1998) | Synthetic agent | Chemotherapy | Intravesical therapy of BCG-refractory carcinoma in situ of the bladder, for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. | |
Bladder cancer | Pembrolizumab (2020) | Biological product | Immunotherapy | Treatment of patients with high-risk non-muscle-invasive bladder cancer without in situ carcinoma and unresponsive to BCG, as well as who were declined or ineligible for radical cystectomy. | |
Esophageal cancer | PDT and porfimer sodium (2003) | Synthetic agent | Combination therapy | Ablation of high-grade dysplasia in Barrett esophagus patients. | |
Cervical cancer and other cancers associated with human papillomavirus vaccine (HPV) infection | HPV vaccine (Gardasil®, 2006) | Biological product | Quadrivalent vaccine for HPV types of 6, 11, 16, and 18. | Indicated in girls and women aged 9-26 for the prevention of the following diseases caused by HPV types included in the vaccine: cervical, vulvar, vaginal, and anal cancers caused by HPV types of 16 and 18, and the following precancerous or dysplastic lesions caused by HPV types of 6, 11, 16, and 18: cervical intraepithelial neoplasia (CIN) grades 1–3 and cervical adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1–3. Indicated in boys and men aged 9-26 for the prevention of the following diseases caused by HPV types included in the vaccine: anal cancer caused by HPV types of 16 and 18, and the following precancerous or dysplastic lesions caused by HPV types of 6, 11, 16, and 18, and AIN grades 1–3. | |
Cervical cancer and other cancers associated with HPV infection | HPV vaccine (Cervarix®, 2009) | Biological product | Bivalent vaccine for HPV types of 16 and 18. | Prevention of cervical cancer, CIN grade≥2 and adenocarcinoma in situ; and CIN grade 1, caused by HPV types of 16 and 18 in girls and women aged 9-25. | |
Cervical cancer and other cancers associated with HPV infection | HPV vaccine (Gardasil® 9, 2014) | Biological product | Nine-valent vaccine for HPV types of 6, 11, 16, 18, 31, 33, 45, 52, and 58. | Indicated in girls and women aged 9-45 for prevention of the following diseases: cervical, vulvar, vaginal, anal, oropharyngeal, and head and neck cancers caused by HPV types of 16, 18, 31, 33, 45, 52, and 58; and the following precancerous or dysplastic lesions caused by HPV types of 6, 11, 16, 18, 31, 33, 45, 52, and 58, CIN grade 2 and 3, and cervical AIS, CIN grade 1, VIN grade 2 and 3, VaIN grade 2 and 3, and AIN grades 1–3. Indicated in boys and men aged 9-45 for the prevention of the following diseases: anal, oropharyngeal and other head and neck cancers caused by HPV types of 16, 18, 31, 33, 45, 52, and 58; and the following precancerous or dysplastic lesions caused by HPV types of 6, 11, 16, 18, 31, 33, 45, 52, and 58, AIN grades 1–3. | |
Hepatocellular carcinoma (HCC) | Hepatitis B vaccine (HBV, Recombivax-HB®, 1986) | Biological product | HBV vaccine | Indicated for prevention of infection caused by all known subtypes of HBV (from birth onward). | |
HCC | HBV (Engerix-B®, 1989) | Biological product | HBV vaccine | Indicated for immunization against infection caused by all known subtypes of HBV (from birth onward). | |
HCC | HBV (Heplisav-B®, 2017) | Biological product | HBV vaccine | Indicated for prevention of infection caused by all known subtypes of HBV (for adults aged 18 years or older). | |
HCC | HBV (PreHevbrio®, 2021)b | Biological product | HBV vaccine | Indicated for prevention of infection caused by all known subtypes of HBV (for adults aged 18 years or older). |
