Pembrolizumab

FDA label information for this drug is available at DailyMed.

Use in Cancer

Pembrolizumab is approved to treat:

• Cervical cancer that is recurrent or metastatic. It is used in patients whose cancer has the PD-L1 protein and whose disease got worse during or after chemotherapy.¹
• Endometrial carcinoma that is advanced and got worse after other systemic therapies. It is used with lenvatinib in patients whose cancer is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and cannot be treated with surgery or radiation therapy.¹
• Gastric (stomach) cancer or gastroesophageal junction cancer (a rare type of esophageal cancer) that is recurrent and either locally advanced or metastatic. It is used in patients whose cancer has the PD-L1 protein and whose disease got worse during or after two or more types of treatment including a fluoropyrimidine and platinum chemotherapy and, in some cases, HER2/neu targeted therapy.¹
• Hepatocellular carcinoma (a type of liver cancer) in patients who have been treated with sorafenib.¹
• Hodgkin lymphoma in adults and children. It is used in patients whose disease is refractory (does not respond to treatment) or has relapsed after at least three other types of treatment.¹
• Melanoma. It is used in:
  • Patients whose cancer cannot be removed by surgery or has metastasized (spread to other parts of the body) or
  • Patients who have had surgery to remove cancer that has spread to the lymph nodes.
• Merkel cell carcinoma in adults and children. It is used in patients whose disease is recurrent and either locally advanced or metastatic.¹
• Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that is metastatic and cannot be removed by surgery. It is used in adults and children for:
  • Solid tumors that have gotten worse after other treatment or that cannot be treated with other therapies.¹
  • Colorectal cancer that has gotten worse after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan hydrochloride.¹

  MSI-H and dMMR cancers have certain genetic mutations and may not respond to some types of treatment.

• Non-small cell lung cancer that has metastasized. It is used:
  • With pemetrexed and platinum chemotherapy as first-line treatment in patients with nonsquamous disease that does not have a mutation in the EGFR gene or ALK gene.
  • With carboplatin and either paclitaxel or paclitaxel albumin-stabilized nanoparticle formulation as first-line treatment for squamous disease.
  • Alone as first-line treatment in patients with stage III disease whose cancer has the PD-L1 protein and does not have a mutation in the EGFR gene or ALK gene. It is used in patients whose cancer cannot be treated with surgery, chemotherapy, or radiation therapy.
  • Alone in patients whose cancer has the PD-L1 protein and got worse during or after treatment with platinum chemotherapy. Patients whose cancer has EGFR or ALK gene mutations should receive pembrolizumab only if their disease got worse after treatment with an FDA-approved therapy for these mutations.
• Primary mediastinal large B-cell lymphoma. It is used in adults and children whose disease is refractory or has relapsed after at least two other therapies.¹
• Renal cell carcinoma (a type of kidney cancer) that is advanced. It is used with axitinib as first-line therapy.¹
• Small cell lung cancer that has metastasized. It is used in patients whose disease got worse during or after treatment with platinum chemotherapy and at least one other therapy.¹
• Squamous cell carcinoma of the esophagus that is recurrent, locally advanced, or metastatic. It is used in patients whose tumors have the PD-L1 protein and whose disease got worse after treatment with systemic therapy.
• Squamous cell carcinoma of the head and neck that has metastasized or recurred (come back). It is used:
  • With platinum chemotherapy and fluorouracil as first-line treatment in patients whose disease cannot be removed by surgery.
  • Alone as first-line treatment in patients whose disease cannot be removed by surgery and whose tumors have the PD-L1 protein.
  • Alone in patients whose disease got worse during or after treatment with platinum chemotherapy.
• Urothelial carcinoma (a type of bladder cancer). It is used in:
  • Patients whose cancer is locally advanced or has metastasized and has the PD-L1 protein and cannot be treated with cisplatin.
  • Patients whose cancer is locally advanced or has metastasized and cannot be treated with platinum chemotherapy or has gotten worse during or after treatment with platinum chemotherapy.¹
  • Patients with carcinoma in situ that is high risk, does not respond to treatment with bacillus Calmette-Guérin (BCG), and has not spread to muscle. It is used in patients whose disease cannot be treated with surgery or who have decided not to have surgery.

¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that pembrolizumab provides a clinical benefit in these patients.

Pembrolizumab is also being studied in the treatment of other types of cancer.

More About Pembrolizumab

Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.

MedlinePlus Information on Pembrolizumab - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Research Results and Related Resources

Monoclonal Antibodies

Immune Checkpoint Inhibitors

Pembrolizumab Approved for Some Patients with Advanced Esophageal Cancer

New Drugs, New Side Effects: Complications of Cancer Immunotherapy

Targeted Therapy–Immunotherapy Combinations Effective for Advanced Kidney Cancer

Pembrolizumab Now Second Immunotherapy Approved to Treat Merkel Cell Carcinoma

Exosomes May Help Tumors Evade Immune System

Combination of Immunotherapy Drugs Approved for Metastatic Colorectal Cancer

New Immunotherapy Option Approved for Cervical Cancer, Rare Lymphoma

FDA Alters Approved Use of Two Checkpoint Inhibitors for Bladder Cancer

Can Age Affect Response to Immune Checkpoint Inhibitors?

Immunotherapy Drugs Expand Treatment Options for Advanced Lung Cancer

For Rare Melanoma, Checkpoint Inhibitors May Hold Substantial Promise

Pembrolizumab Secures FDA Approval in Stomach Cancer

FDA Approves Pembrolizumab for Tumors with Specific Genetic Features

FDA Expands Approval of Pembrolizumab for First-Line Treatment of Non-Small Cell Lung Cancer

FDA Approves Pembrolizumab for Hodgkin Lymphoma

Pembrolizumab Shows Promise in Patients with Rare Form of Skin Cancer

Lung Cancer Precision Medicine Trials: Adapting to Progress

Pembrolizumab Improves Progression-Free Survival in Patients with Ipilimumab-Resistant Melanoma

The Playing Field for Cancer Checkpoint Inhibitors Is Expanding

Pembrolizumab Improves Overall Survival in Patients with Advanced Melanoma

Trial Yields Positive Data on Pembrolizumab for Lung Cancer, Potential Response Biomarker

New Therapies Are Changing the Outlook for Advanced Melanoma

Targeted Cancer Therapies

Clinical Trials Accepting Patients

Find Clinical Trials for Pembrolizumab - Check for trials from NCI's list of cancer clinical trials now accepting patients.