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Locally advanced cutaneous squamous cell carcinoma (CSCC) occurs when tumors become large or have grown deep into underlying tissues, muscles or nerves. Metastatic disease occurs when tumors spread beyond their original location to other parts or organs of the body. Historically, surgery, radiation and chemotherapy were the only treatments for advanced CSCC. For these patients who cannot be cured by surgery or radiation, immunotherapy may be an option. However, in advanced stages, surgery or radiation may no longer be options.
In 2018, the FDA approved the first treatment for people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation..
What is LIBTAYO?
LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
It’s not known if LIBTAYO is safe and effective in children.
LIBTAYO® (cemiplimab-rwlc) is part of a class of immunotherapy drugs known as checkpoint inhibitors and is used to treat people with CSCC that has spread or cannot be cured by surgery or radiation. LIBTAYO is given via intravenous (IV) infusion, meaning it enters your body through a vein, every three weeks for 30 minutes. Your healthcare provider will decide how many treatments you will need.
Immunotherapy is a treatment that uses your body’s immune system to help fight cancer. Your immune system defends your body against disease, and certain white blood cells (T cells) are an important part of your immune system. Their job is to find and fight infections and kill cancer cells. These T cells have a protein on the cell surface called PD-1 (or programmed death receptor-1), which is involved in normal T-cell function.
Some cancer cells are able to trick the immune system to prevent the attack from T cells. When proteins on cancer cells bind to the PD-1 receptor on T cells, this binding makes the T cell inactive and stops it from killing the cancer cell. LIBTAYO is a treatment that works by blocking the PD-1 receptor to inhibit binding with the cancer cell protein. The T cell then remains active so it can attack and kill the cancer cell.
Important Safety Information
What is the most important information I should know about LIBTAYO?
LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affects the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Please see additional Important Safety Information below
Before LIBTAYO, options were limited. Here are five helpful things to consider about LIBTAYO:
1. LIBTAYO may be an option for patients with CSCC that has spread or cannot be cured by surgery or radiation.
Historically, surgery, chemotherapy and radiation were the only options for advanced CSCC. If they didn’t work, there was little a doctor could offer—a situation that could be devastating for patients and their caregivers. One caregiver shared his experience of learning his loved one was out of options: “Chris had tests to see if the surgery had worked; it didn’t,” he said. For Chris and other patients who make up the 5% of CSCC cases that are advanced and cannot be cured by surgery or radiation, LIBTAYO may be an option.
When your CSCC is locally advanced, it has spread deep into the underlying tissue and muscle, so surgery isn’t always a curative option. LIBTAYO gives people with advanced CSCC an option.
“At a minimum, I was looking at major tissue removal across most of the left side of my face if surgery was performed,” said Dave, a LIBTAYO patient ambassador. “My doctor and I decided at that point that surgery or radiation would not be an option as they would likely not be curative.” Dave was instead referred to an oncologist who was treating patients with LIBTAYO.
2. The response rate in clinical trial results
LIBTAYO helped shrink tumors in some clinical trial patients. In one clinical trial of 137 patients with CSCC that had spread or could not be cured by surgery or radiation, 63 of the 137 patients (46%) saw an improvement in their advanced CSCC with LIBTAYO. Of these patients, 43 out of 137 patients (31%) saw tumors shrink (partial response), and 20 out of 137 patients (15%) had a complete response, meaning their tumors disappeared completely.
Additional clinical trial findings have shown 50 out of 63 patients studied (79%) who responded to LIBTAYO had responses that lasted six months or longer. Additionally, 34 out of 63 patients studied (54%) who responded to LIBTAYO had responses that lasted 12 months or longer.
*Patients were dosed by body weight.
In the same clinical trial, in a separate group of 56 patients with CSCC that had spread who took LIBTAYO at the recommended dose(dagger):
23 out of 56 patients (41%) saw an improvement in their advanced CSCC
20 out of 56 patients (36%) saw tumors shrink (partial response)
3 out of 56 patients (5%) saw tumors disappear completely (complete response)
In 15 out of 23 patients (65%) who responded to LIBTAYO, the response lasted 6 months or longer
In this trial, responses lasted between 1.9 months and more than 2 years (24.2+ months); plus sign (+) denotes ongoing at last assessment
LIBTAYO may not work for everyone.
3. How LIBTAYO is administered
LIBTAYO is a medication prescribed by a doctor and given in a hospital via intravenous (IV) infusion, meaning it enters your body through a vein. The schedule for LIBTAYO infusions is every three weeks for 30 minutes. Your healthcare provider will decide how many treatments you will need.
Infusion reactions may happen while you are receiving the drug and can sometimes be severe. Signs of these problems may include nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, back or neck pain, and facial swelling. Tell your doctor right away if you start to experience any of these symptoms.
Important Safety Information (continued)
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:
- Lung problems: cough, shortness of breath, or chest pain
- Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
- Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
- Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
- Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
- Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
- Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
- Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
- Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
- Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.
Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby
Females who are able to become pregnant:
- Your healthcare provider will give you a pregnancy test before you start treatment
- You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk with your healthcare provider about birth control methods that you can use during this time
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO
- are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of LIBTAYO include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.
Please click here for full Prescribing Information, including Medication Guide.
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