Pembrolizumab

FDA label information for this drug is available at DailyMed.

Use in Cancer

Pembrolizumab is approved to treat:

• Breast cancer that is triple negative. Pembrolizumab is used:
  • With chemotherapy in patients whose cancer has the PD-L1 protein and has come back and cannot be removed by surgery or has spread.
  • With chemotherapy before surgery and then alone after surgery in patients with early-stage cancer that has a high risk of coming back.
• Cervical cancer. Pembrolizumab is used:
  • Alone in patients whose cancer is recurrent or metastatic, has the PD-L1 protein, and got worse during or after chemotherapy.
  • With chemotherapy, with or without bevacizumab, in patients whose cancer has the PD-L1 protein and is recurrent or metastatic or did not respond to treatment.
• Classic Hodgkin lymphoma. Pembrolizumab is used:
  • In adults whose cancer is refractory (does not respond to treatment) or has relapsed.
  • In children whose cancer is refractory or has relapsed after at least two other types of treatment.
• Cutaneous squamous cell carcinoma (a type of skin cancer) that is locally advanced, recurrent, or metastatic. Pembrolizumab is used in patients whose cancer cannot be cured by surgery or radiation therapy.
• Endometrial carcinoma that is advanced and got worse after other systemic therapies. Pembrolizumab 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.
• Esophageal or gastroesophageal junction cancer that has spread and cannot be cured by surgery or a combination of chemotherapy and radiation therapy. Pembrolizumab is used:
  • With platinum chemotherapy and a fluoropyrimidine.
  • Alone in patients with squamous cell cancer that has the PD-L1 protein and has been treated with systemic therapy.
• Gastric (stomach) cancer or gastroesophageal junction adenocarcinoma. Pembrolizumab is used:
  • With trastuzumab and a fluoropyrimidine and platinum chemotherapy as the first treatment in patients whose cancer is HER2 positive and has spread or cannot be treated with surgery.¹
  • Alone in patients whose cancer has the PD-L1 protein and has come back or spread. Pembrolizumab is used in patients whose cancer got worse during or after at least two treatments with a fluoropyrimidine and platinum chemotherapy and, in some cases, HER2-targeted therapy.
• Hepatocellular carcinoma (a type of liver cancer) in patients who have been treated with sorafenib.¹
• Melanoma. Pembrolizumab 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. Pembrolizumab is used in patients whose cancer has come back or spread.¹
• Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that is metastatic or cannot be removed by surgery. Pembrolizumab is used to treat:
  • Solid tumors in adults and children that got worse after other treatment and cannot be treated with other therapies.¹
  • Colorectal cancer.

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

• Non-small cell lung cancer. Pembrolizumab is used:
  • With pemetrexed and platinum chemotherapy as the first treatment in patients with nonsquamous metastatic cancer 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 the first treatment for metastatic squamous cancer.
  • Alone as the first treatment in patients whose cancer has the PD-L1 protein and does not have a mutation in the EGFR gene or ALK gene. Pembrolizumab is used in patients with stage III cancer that cannot be treated with surgery, chemotherapy, or radiation therapy. It is also used in patients with metastatic cancer.
  • Alone in patients whose cancer is metastatic, has the PD-L1 protein, and has gotten 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. Pembrolizumab is used in adults and children whose cancer is refractory or has returned after at least two other therapies.
• Renal cell carcinoma (a type of kidney cancer) that is advanced. Pembrolizumab is used with axitinib or lenvatinib in adults as the first treatment.
• Solid tumors that are tumor mutational burden-high (TMB-H) and are metastatic or cannot be removed by surgery. Pembrolizumab is used in adults and children whose cancer got worse after treatment and who are not able to receive other therapies.¹
• Squamous cell carcinoma of the head and neck that is recurrent or metastatic. Pembrolizumab is used:
  • With platinum chemotherapy and fluorouracil as the first treatment in patients whose cancer cannot be removed by surgery.
  • Alone as the first treatment in patients whose cancer treatment in patients whose cancer cannot be removed by surgery and whose tumors have the PD-L1 protein.
  • Alone in patients whose cancer got worse during or after treatment with platinum chemotherapy.
• Urothelial carcinoma (a type of bladder cancer). Pembrolizumab is used in:
  • Patients whose cancer has spread and cannot be treated with platinum chemotherapy or has gotten worse during or after treatment with platinum chemotherapy.
  • 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. Pembrolizumab 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

Pembrolizumab May Help Prevent Early-Stage Melanoma from Returning

Targeted Cancer Therapies

Study Details Long-Term Side Effects of Immune Checkpoint Inhibitors

For Esophageal Cancer, Immunotherapy Likely to Play Larger Role

A New FDA Approval Furthers the Role of Genomics in Cancer Care

Monoclonal Antibodies

Immune Checkpoint Inhibitors

New Drugs, New Side Effects: Complications of Cancer Immunotherapy

Clinical Trials Accepting Patients

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