FDA Approves Libtayo® for Locally Advanced and Metastatic Basal Cell Carcinoma

The U.S. Food and Drug Administration has approved Libtayo® (cemiplimab-rwlc) to treat certain types of locally advanced (cannot be removed by surgery) and metastatic (has spread) basal cell carcinoma (BCC).1

The FDA approves Libtayo® for certain BCC

Libtayo is now approved for people with locally advanced BCC who were:1

  • Previously treated with an HHI (hedgehog pathway inhibitor), or
  • Unable to receive treatment with an HHI

HHIs are drugs that may be used to treat BCC that has spread to other parts of the body.

Libtayo was also granted accelerated approval for use in people with metastatic BCC who were:1

  • Previously treated with an HHI, or
  • Unable to receive treatment with an HHI

The FDA may give accelerated approval to new drugs that treat a health condition with few or no other treatments. This means drugs like Libtayo can be sold sooner.

Libtayo was already approved to treat people with cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.1

What are the ingredients in Libtayo?

The active ingredient in Libtayo is cemiplimab-rwlc.2

How does Libtayo work?

Libtayo is a monoclonal antibody. Monoclonal antibodies are created in a laboratory to attach to specific antigens (such as germs) on the surface of cancer cells.1,2

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. When the pathway is blocked, the body’s immune system is able to fight the cancer.1,2

Evidence for Libtayo

Libtayo was approved based on the results of Study 1620. It is an ongoing, open-label, multi-center, non-randomized trial. The study looked at people with advanced BCC (locally advanced or metastatic):1

  • Whose cancer had progressed (spread or grew larger) while taking an HHI
  • Whose cancer had not changed after taking an HHI for 9 months
  • Who could not take an HHI

The people in the study could not be candidates to have surgery to remove their cancer or receive radiation. All study participants received Libtayo every 3 weeks for up to 93 weeks until:1,2

  • Their cancer progressed (spread or grew larger)
  • The dosage could not be increased without causing harm (toxicity) to the body
  • Treatment was complete

In 84 people with locally advanced basal carcinoma, 29 percent had their cancer shrink or disappear after treatment. Of those people, 79 percent maintained this response for at least 6 months after treatment.1,2

In 28 people with metastatic basal cell carcinoma, 21 percent had their cancer shrink or disappear after treatment. All 28 people maintained this response for at least 6 months after treatment.1,2

What are the possible side effects of Libtayo?

The most common side effects of Libtayo include:1

  • Fatigue
  • Musculoskeletal pain
  • Diarrhea
  • Rash/itching

Other severe side effects may occur. These include:1,2

  • Reactions caused by a weakened immune system, like thyroid problems, kidney issues, diabetes, or inflammation of the lungs, liver, or colon
  • Reactions at the drug infusion site, 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:1,2

  • 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.

Before beginning treatment for skin 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 Libtayo.

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