What Is Keytruda® (pembrolizumab)?

The U.S. Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer. For this approval, Keytruda must be combined with chemotherapy and the tumor must express the PD-L1 protein as measured by an FDA-approved test.1

Triple-negative breast cancer is a difficult-to-treat and aggressive cancer. Up to 1 in 5 people with breast cancer have triple-negative cancer.2

Accelerated approval is granted to new drugs that are very promising and could make a positive impact on the treatment of serious conditions. This process helps drugs like Keytruda become available sooner.

What are the active ingredients of Keytruda (pembrolizumab)?

Keytruda contains a programmed death receptor-1 (PD-1) blocking antibody.

How does Keytruda (pembrolizumab) work?

Keytruda is a monoclonal antibody, which is a type of immunotherapy. Monoclonal antibodies are created in the lab to mimic the antibodies that are naturally produced by the body to kill germs. Antibodies can also target specific areas of cancer cells to block cancer growth or kill cancer cells.

Keytruda attaches to the surface of cancer cells on the PD-1 receptor. By blocking how PD-1 works, Keytruda can help the body’s T-cells and immune system fight cancer.

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In the Keynote-355 clinical trial, Keytruda was used in combination with the chemotherapies paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin. Keytruda is given by injection.2

What are the possible side effects of Keytruda (pembrolizumab)?

The most common side effects of taking Keytruda with chemotherapy are1:

  • Fatigue
  • Nausea, diarrhea, constipation, and vomiting
  • Hair loss (alopecia)
  • Rash
  • Cough/li>
  • Decreased appetite
  • Headache
  • Low red blood cell count (anemia)/li>
  • Low white cell or platelet counts

In some people, Keytruda may cause more serious, sometimes life-threatening side effects. These include3:

  • Lung problems, called pneumonitis
  • Intestinal problems, called colitis
  • Liver problems, called hepatitis
  • Endocrine gland problems
  • Kidney problems, called nephritis
  • Severe skin reactions
  • Organ transplant rejection

These are not all the possible side effects of Keytruda. Patients should talk to their doctor about what to expect with treatment with Keytruda.

Things to know about Keytruda (pembrolizumab)

Keytruda also has been approved to treat several other types of cancer, including certain types of lung, skin, bladder, cervical, colon, kidney, and blood cancers.3

Before starting treatment with Keytruda, patients should talk to their doctor about all medications (prescription and over-the-counter), vitamins, and herbal supplements they are taking. Some medications or supplements may interfere with each other and may cause side effects.

For more information, read the full prescribing information of Keytruda (pembrolizumab).

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