HOW DOES
KEYTRUDA WORK?

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat:

• a kind of skin cancer called melanoma.
• • It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma), or
  • It may be used to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
• a kind of lung cancer called non–small cell lung cancer (NSCLC).
• • It may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “nonsquamous” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
  • It may be used with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel protein-bound as your first treatment when your lung cancer has spread (advanced NSCLC), and is a type called “squamous.”
  • It may be used alone as your first treatment when your lung cancer has not spread outside your chest (stage III) and you cannot have surgery or chemotherapy with radiation, or your NSCLC has spread to other areas of your body (advanced NSCLC), and your tumor tests positive for “PD-L1” and does not have an abnormal “EGFR” or “ALK” gene.
  • It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and, your tumor tests positive for “PD-L1” and if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
• a kind of cancer called head and neck squamous cell cancer (HNSCC).
• • It may be used with the chemotherapy medicines fluorouracil and a platinum as your first treatment when your head and neck cancer has spread or returned and cannot be removed by surgery.
  • It may be used alone as your first treatment when your head and neck cancer has spread or returned and cannot be removed by surgery, and your tumor tests positive for “PD-L1.”
  • It may be used alone when your head and neck cancer has spread or returned, and you have received chemotherapy that contains platinum and it did not work or is no longer working.
• a kind of cancer called classical Hodgkin lymphoma (cHL). It may be used
• • in adults when:
  • • your cHL has returned or
    • you have tried a treatment and it did not work, or
  • in children when:
  • • you have tried a treatment and it did not work, or
    • your cHL has returned after you received 2 or more types of treatment.
• a kind of cancer called primary mediastinal B-cell lymphoma (PMBCL). It may be used in adults and children when you have tried a treatment and it did not work, or your PMBCL has returned after you received 2 or more types of treatment.
• a kind of bladder cancer called urothelial carcinoma. It may be used when your cancer has not spread to nearby tissue in the bladder, but is at high-risk for spreading (high-risk, non-muscle invasive bladder cancer [NMIBC]) and when your tumor is a type called “carcinoma in situ” (CIS), and you have tried treatment with Bacillus Calmette-Guerin (BCG) and it did not work, and you are not able to or have decided not to have surgery to remove your bladder.
• a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. It may be used in adults and children to treat:
• • cancer that has spread or cannot be removed by surgery (advanced cancer), and
  • has progressed following treatment, and you have no satisfactory treatment options, or
  • you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
• This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
  It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
• a kind of cancer called colon or rectal cancer. It may be used as your first treatment when your cancer:
• • has spread or cannot be removed by surgery (advanced colon or rectal cancer), and
  • has been shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
• a kind of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that tests positive for “PD-L1.” It may be used when your stomach cancer:
• • has returned or spread (advanced gastric cancer), and
  • you have received 2 or more types of chemotherapy including fluoropyrimidine and chemotherapy that contains platinum, and it did not work or is no longer working, and
  • if your tumor has an abnormal “HER2/neu” gene, you also received a HER2/neu-targeted medicine and it did not work or is no longer working.
• This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
• a kind of cancer called esophageal or certain gastroesophageal junction (GEJ) carcinomas that cannot be cured by surgery or a combination of chemotherapy and radiation therapy.
• • It may be used with platinum- and fluoropyrimidine-based chemotherapy medicines.
  • It may be used alone when:
  • • you have received one or more types of treatment, and it did not work or it is no longer working, and
    • your tumor is a type called “squamous,” and
    • your tumor tests positive for “PD-L1.”
• a kind of cancer called cervical cancer that tests positive for “PD-L1.” It may be used when your cervical cancer has returned or has spread or cannot be removed by surgery (advanced cervical cancer), and you have received chemotherapy, and it did not work or is no longer working.
• This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
• a kind of liver cancer called hepatocellular carcinoma. It may be used after you have received the medicine sorafenib.
• This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
• a kind of skin cancer called Merkel cell carcinoma (MCC) in adults and children. It may be used when your cancer has spread or returned.
• This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
• a kind of kidney cancer called renal cell carcinoma (RCC). It may be used with the medicine axitinib as your first treatment when your kidney cancer has spread or cannot be removed by surgery (advanced RCC).
• a kind of skin cancer called cutaneous squamous cell carcinoma (cSCC). It may be used when your skin cancer has returned or spread, and cannot be cured by surgery or radiation.
• a kind of cancer called triple-negative breast cancer (TNBC).
• • It may be used with chemotherapy medicines as treatment before surgery and then continued alone after surgery when you have early-stage breast cancer, and are at high risk of your breast cancer coming back (high-risk early-stage triple-negative breast cancer [TNBC]).
  • It may be used with chemotherapy medicines when your breast cancer has returned and cannot be removed by surgery or has spread (advanced TNBC), and tests positive for “PD-L1.”

PD-L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase;
HER2/neu = human epidermal growth factor receptor 2.