Frequently asked questions

Here are some frequently asked questions that patients may have about advanced NSCLC and treatment with LIBTAYO. Remember that this information is not meant to take the place of talking to your doctor. Your doctor is the best source of information about your condition.

Below are questions about advanced NSCLC and treatment with LIBTAYO.

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Non–small cell lung cancer (NSCLC) is the most common type of lung cancer. About 85% of lung cancers are NSCLC. It typically grows and spreads more slowly. When NSCLC is diagnosed as stage 3 or stage 4, it is considered advanced.

Types of NSCLC that are the most commonly diagnosed:

Adenocarcinoma (A-deh-noh-KAR-sih-NOH-muh) begins in cells of glands that normally secrete substances such as mucus and are often found in an outer area of the lungs.

Large cell carcinoma (... sel KAR-sih-NOH-muh) can occur in any part of the lungs and tends to grow and spread faster than adenocarcinoma or squamous cell carcinoma.

Squamous cell carcinoma (SKWAY-mus sel KAR-sih-NOH-muh) begins in the flat cells that line the passages of the respiratory tract and are found in the center of the lungs next to an air tube (bronchus).

Learn more about NSCLC, including
advanced NSCLC

After an NSCLC diagnosis, one of the first steps doctors will take is to try to determine the size of the cancer in the body and where it is located. This is called staging. The stage of NSCLC mainly describes the size of the tumor and if it has spread to other areas of the body. The lower the stage number, the less advanced the cancer is.

There are different staging systems for different cancers, but the most common is the numbered cancer staging system that identifies 5 possible cancer stages:

Stage 0: Cancer cells are located in the lining of the airways and have not spread.

Stage 1: The cancer is still small and has not spread outside the lungs or to the lymph nodes.*

Stage 2: The cancer may be larger than in stage 1 or may have spread to the lymph nodes* near where the cancer started.

Stage 3: The cancer may have spread to the lymph nodes* farther away from where it started within the chest. The cancer has not spread to other parts of the body and may be larger than those in stage 2. It is sometimes referred to as locally advanced NSCLC.

Stage 4: The most advanced form of cancer. In stage 4 cancer, the disease is called metastatic NSCLC, which means that the cancer has spread to other organs such as the other lung, brain, liver, or to other parts of the body.

*Lymph nodes are like filters that remove germs. They contain immune cells that can help fight infection.

Learn more about the
stages of NSCLC

When NSCLC is diagnosed as stage 3, it means the cancer may have spread to the lymph nodes* farther away from where it started within the chest. The cancer has not spread to other parts of the body and may be larger than those in stage 2. It is sometimes referred to as locally advanced NSCLC. Stage 4 is the most advanced form of cancer. In stage 4 cancer, the disease is called metastatic NSCLC, which means that the cancer has spread to other organs such as the other lung, brain, liver, or to other parts of the body.

*Lymph nodes are like filters that remove germs. They contain immune cells that can help fight infection.

Learn more about the
stages of NSCLC

Biomarker testing is an important part of understanding your unique advanced NSCLC diagnosis. It is used in the advanced stages of NSCLC and involves testing tumor tissue for mutations or abnormalities in the DNA and levels of specific proteins in, or on the surface of, the tumor. Biomarkers tell your doctor that a mutation or an abnormality may be present and may lead to a better understanding of which treatment to use and how you may respond to treatment.

There are many different biomarker tests that may help you and your doctor decide the most appropriate treatment options to help treat your advanced NSCLC. Your doctor may test you for more than one biomarker. Below are some of the most common types of biomarkers.

  • Epidermal growth factor receptor (EGFR)
  • Anaplastic lymphoma kinase (ALK)
  • ROS proto-oncogene 1, receptor tyrosine kinase (ROS1)
  • B-Raf proto-oncogene, serine/threonine kinase (BRAF)
  • Neurotrophic tyrosine receptor kinase (NTRK)
  • Programmed death ligand 1 (PD-L1)
Learn more about
these biomarkers

ALK, EGFR, and ROS1 are some of the biomarkers found in advanced NSCLC. Your doctor may test you for more than one of these biomarkers to help decide the most appropriate treatment options to help treat your advanced NSCLC. Treatment options may be appropriate for you based on the absence or presence of certain biomarkers.

Anaplastic lymphoma kinase (A-nuh-PLAS-tik lim-FOH-muh KY-nays) (ALK)

The ALK gene causes cells to grow and divide more rapidly. ALK mutations may cause tumors to grow out of control. LIBTAYO is not an appropriate therapy for patients who test positive for ALK mutations.

Epidermal growth factor receptor (eh-pih-DER-mul grothe FAK-ter reh-SEP-ter) (EGFR)

The EGFR protein is involved in cell growth and cell survival. EGFR mutations may cause cancer cells to grow and spread in the body more rapidly. LIBTAYO is not an appropriate therapy for patients who test positive for EGFR mutations.

ROS proto-oncogene 1, receptor tyrosine kinase (ros prow-tuh-aang-kow-jeen wuhn, reh-SEP-ter TY-ruh-seen KY-nays) (ROS1)

The ROS1 protein is involved in sending signals in cells and in cell growth. ROS1 mutations may cause cancer cells to grow. LIBTAYO is not an appropriate therapy for patients who test positive for ROS1 mutations.

Learn more about
biomarker testing

PD-L1 is a protein that acts as a kind of “brake” to keep the body’s immune responses under control. PD-L1 binds to another protein found on T cells called programmed death receptor-1 (PD-1). This binding keeps T cells from killing normal cells and cancer cells that contain PD-L1.

Learn more about PD-L1
and why it is important to know
your biomarker status

Yes, you will need a biomarker test before starting LIBTAYO. If your cancer tested positive for PD-L1 at a level greater than or equal to 50% and if you tested negative for abnormal EGFR, ALK, and ROS1 biomarkers, LIBTAYO may be an appropriate treatment option for your advanced NSCLC.

Learn more about
biomarker testing

LIBTAYO is not chemotherapy or radiation therapy. LIBTAYO is a type of immunotherapy treatment called a programmed death receptor-1 (PD-1) inhibitor.

Learn more about how
LIBTAYO works

Immunotherapy is a form of systemic drug therapy (a type of drug that moves through the body) that may help your immune system fight cancer. Your body might not attack cancer because the cancer cells have developed ways to avoid the immune system and keep growing. Immunotherapy helps the immune system recognize, attack, and kill the cancer cells. Immunotherapy is given by an oncologist and often used during the advanced stages (stages 3 and 4). It is not chemotherapy.

Immunotherapy can also cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work.

Learn more about how
LIBTAYO works

LIBTAYO is a medicine that may treat certain types of 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 affect 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.

See the most important
information about LIBTAYO

LIBTAYO can cause serious side effects, including:

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. Make sure to read all of the important information about LIBTAYO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See the most important
information about LIBTAYO
See the most common side effects
that occurred in the LIBTAYO study

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 with LIBTAYO
  • You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of LIBTAYO. Talk to 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.

See the most important
information about LIBTAYO
  • Your healthcare provider will give you LIBTAYO into your vein through an intravenous (IV) line over 30 minutes
  • LIBTAYO is usually given every 3 weeks
  • Your healthcare provider will decide how many treatments you will need
  • Your healthcare provider will do blood tests to check you for side effects
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment
Learn more about taking LIBTAYO

Every person is different and not everyone will respond to LIBTAYO the same way. LIBTAYO may not work for some people with advanced NSCLC. If you have any questions about treatment with LIBTAYO, talk to your doctor.

Learn more about patient
responses in the LIBTAYO trial

LIBTAYO Surround offers patient support that may help with access to medication, including financial support when eligible patients need assistance with out-of-pocket costs.

LIBTAYO is covered by most major insurers, and LIBTAYO Surround may help you access LIBTAYO and navigate the health insurance process.

Learn more about how
LIBTAYO Surround may help

Review the most important safety information you should know about LIBTAYO.

Important information
about LIBTAYO