Libtayo® (cemiplimab-rwlc)

Libtayo® (cemiplimab-rwlc) is approved as a first-line treatment for adults with certain forms of advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression of 50 percent or more.1,2

Certain cancer cells have large amounts of the protein PD-L1. The PD-L1 protein can interact with another protein, known as PD-1, found on some immune system cells, which can help the cancer cells avoid detection by the immune system. Libtayo targets PD-1, blocking this interaction and allowing the immune system to detect and attack the cancer cells.1,2

The U.S. Food and Drug Administration (FDA) approved Libtayo for NSCLC under a Priority Review. The FDA can grant Priority Review when a new drug seems promising and may help treat a disease compared to existing treatments. Priority Review means the FDA will typically review the drug and decide whether to grant approval within 6 months. It may be applied in cases where a given drug seems to work better or is safer than current treatments.2

Libtayo is also approved to treat people with certain forms of basal cell carcinoma and cutaneous squamous cell carcinoma.3

What are the ingredients in Libtayo?

The active ingredient in Libtayo is cemiplimab-rwlc.3

How does Libtayo work?

Libtayo is a monoclonal antibody. Monoclonal antibodies are created in a laboratory to attach to specific antigens on the surface of certain cells, including cancerous and/or immune cells.3,4

Antibodies are a normal part of the immune system. They attach to antigens to mark them for destruction by the immune system. Libtayo targets the PD-1 receptor and binds, or “sticks,” to it. By binding to PD-1, Libtayo blocks cancer cells from using the PD-1 pathway to avoid detection by the immune system. When the pathway is blocked, the body’s immune system is able to fight the cancer.3,4

What are the possible side effects of Libtayo?

The most common side effects of Libtayo include:2,3

  • Fatigue
  • Musculoskeletal pain
  • Diarrhea
  • Rash

Other severe side effects may occur. These include:3

  • Reactions caused by the immune system, such as hormone gland issues, kidney issues, skin reactions, or inflammation of the lungs, liver, or colon
  • Reactions to the medication infusion, like chills, rash, flushing, difficulty breathing, dizziness, fever, back/neck pain, facial swelling

If you experience any side effects that may be life-threatening, contact 911 right away.

These are not all the possible side effects of Libtayo. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Libtayo.

Things to know about Libtayo

Libtayo can affect your immune system and cause it to attack normal organs and tissues. These problems may become severe or life-threatening. Before taking Libtayo, tell your doctor if you have:3

  • Immune system problems like Crohn’s disease, ulcerative colitis, or lupus
  • Had an organ transplant
  • Lung or breathing problems
  • Liver or kidney problems
  • Diabetes

Libtayo can harm an unborn baby. Women who can become pregnant should use birth control during treatment and for some time after the last dose of Libtayo. Women should also not breastfeed during treatment with Libtayo and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Libtayo.3

Before beginning treatment for lung cancer, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Libayo.

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Written by: Karen Berger | Last reviewed: May 2021