Indications

What is IMDELLTRA® (tarlatamab-dlle)? IMDELLTRA® is a prescription medicine used to treat adults with extensive stage small cell lung cancer (ES-SCLC), which is cancer that has spread throughout
the lung or to other parts of the body, and who have received treatment with chemotherapy that contains platinum, and it did not work or…READ MORE IMDELLTRA® is a prescription medicine used to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which is cancer …READ MORE

What is IMDELLTRA® (tarlatamab-dlle)?

IMDELLTRA® is a prescription medicine used to treat adults with extensive stage small cell lung cancer (ES-SCLC), which is cancer that has spread throughout
the lung or to other parts of the body, and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.

It is not known if IMDELLTRA® is safe and effective in children. READ LESS

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Frequently asked questions about IMDELLTRA® and extensive stage small cell lung cancer (ES-SCLC)

Not actual people with ES-SCLC.

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An ES-SCLC diagnosis opens up countless questions. We’ve brought some of the most common ones here to help you. Don’t forget that your health care team is an important resource to answering questions about how this affects you.

General Information

  • What is IMDELLTRA® (tarlatamab-dlle)?

    IMDELLTRA® is a T-cell (a type of immune cell in the body) engager and is designed to use your body’s immune system to help fight SCLC cells. IMDELLTRA® helps the immune system recognize specific molecules on their surface, helping to target and destroy cancer cells.1,2

  • Is IMDELLTRA® chemotherapy or immunotherapy?

    IMDELLTRA® is immunotherapy because it helps a person’s immune system destroy the cancer cells. This is different from chemotherapy, which uses drugs to stop the growth of cancer cells by killing the cells or by stopping them from dividing.1-3

  • What is small cell lung cancer (SCLC)?

    SCLC is an aggressive type of cancer that starts in the lungs and spreads quickly. There are 2 stages, limited stage and extensive stage, and that’s split based on how much the cancer has grown or spread. IMDELLTRA® is approved by the FDA for adults with extensive stage SCLC.1,3,4

IMDELLTRA® in Clinical Trials

  • How did IMDELLTRA® perform in a clinical study in SCLC?

    A study compared how long people with extensive stage small cell lung cancer (ES-SCLC) lived with IMDELLTRA® compared with chemotherapy. 509 people whose cancer worsened after receiving treatment with chemotherapy containing platinum were included. About half (254 people) were randomly assigned to receive IMDELLTRA®, and the other half (255 people) were assigned to receive chemotherapy.1

    Half of the people receiving IMDELLTRA® were alive for more than 1 year (13.6 months) after starting treatment. Half of the people receiving chemotherapy were alive for 8.3 months after starting treatment.1

    See more details on treatment

  • Has IMDELLTRA® been FDA-approved?

    Yes, IMDELLTRA® has been approved by the FDA as of November 2025, for adults with extensive stage small cell lung cancer (ES-SCLC).5

Safety and Side Effects

  • What are the side effects of IMDELLTRA®?

    IMDELLTRA® can cause serious side effects that can be severe, life-threatening, or cause death, including cytokine release syndrome (CRS) and neurologic problems. Other serious side effects include low blood cell counts, infections, liver problems, and allergic reactions. The most common side effects include tiredness, decreased appetite, a bad or metallic taste in your mouth, fever, muscle or bone pain, constipation, and nausea.6 Please go to our Side Effects page for the full list.

    See side effects

  • What is cytokine release syndrome (CRS), and how is it managed?

    CRS is a condition that happens when your immune system reacts harshly to an immunotherapy.7 It is common during treatment with IMDELLTRA® and can also be severe, life-threatening, or cause death.6 In clinical studies, 73% of CRS events in people who were given IMDELLTRA® occurred after the first dose, and 60% occurred after the second dose. 15% of CRS events happened after the third or later dose.1 Your health care provider will monitor you for signs and symptoms of CRS during treatment with IMDELLTRA® and treat you as needed. You may be hospitalized if you develop signs or symptoms of CRS during treatment with IMDELLTRA®. Your health care provider may temporarily stop or completely stop your treatment with IMDELLTRA® if you develop CRS.6

  • What neurologic problems could IMDELLTRA® cause as a side effect, and how are they monitored?

    IMDELLTRA® can cause neurologic problems that can be severe, life-threatening, or cause death. Neurologic problems may happen days or weeks after you receive IMDELLTRA®. Your health care provider may refer you to another health care provider who specializes in neurologic problems. Your health care provider will monitor you for signs and symptoms of neurologic problems during treatment with IMDELLTRA® and treat you as needed. You may be hospitalized if you develop signs or symptoms of neurologic problems during treatment with IMDELLTRA®. Your health care provider may temporarily stop or completely stop your treatment with IMDELLTRA® if you develop neurologic problems.6 Review our Side Effects page for possible signs or symptoms.

    See side effects

  • How soon could CRS and neurologic side effects happen after starting treatment?

    Side effects can happen at different times for each person. In clinical trials, CRS usually began about 16 hours after the most recent dose of IMDELLTRA®. Neurologic side effects tended to occur starting around 16 days after the first dose. Your health care team will monitor you in an appropriate health care setting to help manage side effects.1,6

  • Are there monitoring requirements for patients on IMDELLTRA®?

    IMDELLTRA® has a step-up dosing schedule that may include being monitored in an appropriate health care facility overnight for the first two doses.1,6 For the full monitoring requirements, visit our Dosing & Treatment Process page.

    Monitoring schedule

Dosing and Treatment Steps

  • How is IMDELLTRA® given?

    IMDELLTRA® is given by intravenous (IV) infusion over the course of about one hour at a health care facility. Due to the risk of CRS and neurological problems, your health care provider will monitor you to help manage any potential side effects.1,6

  • What is the dosing schedule for IMDELLTRA®?

    IMDELLTRA® uses a step-up dosing schedule, which means the first dose of IMDELLTRA® will be 1 mg on the first day, then goes to the full treatment dose of 10 mg on day 8, 10 mg on day 15, and 10 mg every two weeks after.1,6

  • Are there recommended steps to prepare for my IMDELLTRA® appointment?

    Bring someone to your appointments and any questions you may have for your health care team. Consider bringing a journal with notes about how you’re feeling every day. Your health care provider will ask you about your medical conditions. Depending on where you are in the dosing cycle, and how you respond to treatment, you may be staying overnight in a healthcare facility, so talk to the facility staff about what you might need.6

Cost and Financial Assistance

  • Does insurance cover IMDELLTRA®?

    An Amgen Patient Navigator is ready to answer your questions, like understanding your treatment journey, helping you understand your coverage, verify your benefits, and more. You can speak with an Amgen Patient Navigator directly at (844) 992-6436, Monday - Friday 8:00 AM - 8:00 PM ET, or visit AmgenSupportPlus.com to learn how Amgen can help.

    The Amgen Patient Navigator is not part of a patient’s treatment team and does not provide medical advice or case management services. The Amgen Patient Navigator does not administer Amgen medications. Patients should always consult their health care provider regarding medical decisions or treatment concerns.

    Connect With an
    Amgen Patient
    Navigator

  • How do deductibles and co-pays affect the out-of-pocket cost?

    Amgen has a SupportPlus Co-Pay Program, which may help patients with private or commercial insurance lower their out-of-pocket costs. There is no income eligibility requirement, and it can be applied to deductible, co-insurance, and co-payment* so you could pay as little as $0* out-of-pocket for each dose.

    Check your eligibility and sign up today at www.AmgenSupportPlus.com/copay

    *Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay for full Terms and Conditions.

  • What financial assistance programs are available?

    Amgen® SupportPlus can provide information about independent nonprofit foundations that may be able to help.† Call Amgen SupportPlus at (866) 264-2778, Monday - Friday 8:00 AM - 8:00 PM, or visit AmgenSupportPlus.com to learn more.

    †Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofit’s criteria. Amgen has no control over these programs and provides information as a courtesy only.

Access and Support

  • How do I get started on IMDELLTRA®?

    Talk to your health care team, and together, you'll decide if IMDELLTRA® is right for you.

  • Are there patient communities or support groups for people receiving IMDELLTRA®?

    Remember that there are local and national supportive resources and community organizations that may be helpful to you. They can offer information about SCLC and provide a place to share your experience or hear about other patients’ experiences. For a list of some third-party resources, visit our Support and Resources page.

    Find resources

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMDELLTRA®?

IMDELLTRA® can cause side effects that can be severe, life-threatening or cause death, including:

  • Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA® and can be
    severe, life-threatening, or cause death. Tell your healthcare provider or get medical help right away if you
    develop any signs or symptoms of CRS, including:

  • fever of 100.4ºF (38ºC) or higher
  • low blood pressure
  • tiredness
  • fast heartbeat or dizziness
  • headache
  • shortness of breath or trouble breathing
  • nausea and vomiting
  • confusion, restlessness, or feeling anxious
  • problems with balance and movement, such as trouble walking
  • heart, liver, or kidney problems
  • blood clots or unusual bleeding or bleeding that lasts a long time

Due to the risk of CRS, you will receive IMDELLTRA® as per the following “step-up dosing schedule”:

  • The step-up dosing schedule is when you receive a smaller dose of IMDELLTRA® on Day 1 of your first
    treatment cycle (Cycle 1).
  • You will receive the full treatment dose of IMDELLTRA® on Day 8 and Day 15 of Cycle 1. You will receive
    the full treatment dose 1 time every 2 weeks after Day 15 of Cycle 1.
  • If your dose of IMDELLTRA® is delayed for any reason, you may need to repeat the “step-up dosing
    schedule”.
  • Before receiving your Day 1 and Day 8 doses of Cycle 1 of IMDELLTRA®, you will be given a medicine to
    help reduce your risk of CRS. This will be given into your vein by intravenous (IV) infusion. You will also
    receive IV fluids after each of your Cycle 1 Day 1 and Day 8 doses. Your healthcare provider will decide if
    you need to receive medicines to help reduce your risk of CRS with future doses.

  • Neurologic Problems. IMDELLTRA® can cause neurologic problems that can be severe, life-threatening, or cause death. Neurologic problems may happen days or weeks after you receive IMDELLTRA®. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your
    healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:

  • changes in taste
  • headache
  • numbness or tingling of your hands or feet
  • dizziness
  • trouble sleeping
  • muscle weakness or numbness of arms or legs
  • problems with walking, or loss of balance or coordination
  • trouble speaking, memory loss, or personality changes
  • confusion, feeling disoriented, slow thinking, or
    not being able to think clearly
  • fainting or loss of consciousness
  • seizures
  • shaking (tremors)
  • sleepiness
  • feeling like you have no energy

Due to the risk of CRS and neurologic problems, you will receive the following monitoring during treatment with IMDELLTRA®:

  • For Day 1 and Day 8 of Cycle 1 doses, your healthcare provider will monitor you for 22 to 24 hours from the start of the IMDELLTRA® infusion in a healthcare setting that can manage these side effects.
  • You should remain within 1 hour of a healthcare setting for a total of 48 hours from the start of the IMDELLTRA® infusion after your Day 1 and Day 8 of Cycle 1 doses and be accompanied by a caregiver.
  • For Day 15 of Cycle 1 and Cycle 2 doses, your healthcare provider will watch you for 6 to 8 hours after the IMDELLTRA® infusion.
  • For Cycle 3 and Cycle 4 doses, your healthcare provider will watch you for 3 to 4 hours after the IMDELLTRA® infusion.
  • For Cycle 5 and later doses, your healthcare provider will watch you for 2 hours after the IMDELLTRA® infusion.

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with IMDELLTRA® and treat you as needed. You may be hospitalized if you develop signs or symptoms of CRS or neurologic problems during treatment with IMDELLTRA®. Your healthcare provider may temporarily stop or completely stop your treatment with IMDELLTRA® if you develop CRS or neurologic problems.

Before receiving IMDELLTRA®, tell your healthcare provider about all of your medical conditions,
including if you:

  • have an infection
  • are pregnant or plan to become pregnant. IMDELLTRA® may harm your unborn baby.

Females who are able to become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with IMDELLTRA®.
  • You should use an effective form of birth control (contraception) during treatment with IMDELLTRA®, and for 2 months after the last dose of IMDELLTRA®.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with IMDELLTRA®.
  • are breastfeeding or plan to breastfeed. It is not known if IMDELLTRA® passes into your breast milk. Do not breastfeed during treatment with IMDELLTRA® and for 2 months after the last dose of IMDELLTRA®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-
counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving IMDELLTRA®?

Do not drive, operate heavy or potentially dangerous machinery or do other dangerous activities, including work-related activities, during treatment with IMDELLTRA® if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.

What are the possible side effects of IMDELLTRA®?

IMDELLTRA® can cause serious side effects, including:

  • Low blood cell counts (cytopenia). Decreased blood cell counts can be severe and may include the following:

  • low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection.
  • low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath.
  • low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.
  • Infections. IMDELLTRA® can cause serious infections that can be life-threatening and cause death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment with IMDELLTRA®. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with IMDELLTRA®, including: fever of 100.4ºF (38ºC) or higher; painful rash, cough, sore throat or runny nose, chest pain, pain during urination, tiredness, feeling weak or generally unwell,
    shortness of breath, yeast infections in the mouth or other areas.
  • Liver problems. IMDELLTRA® can cause increased liver enzymes and bilirubin in your blood. These
    increases can happen with or without you also having CRS. Tell your healthcare provider right away if you
    develop any signs or symptoms of liver problems, including: tiredness, dark urine, loss of appetite,
    yellowing of your skin or the white part of your eyes, pain in your right upper stomach-area (abdomen).
  • Allergic reactions. IMDELLTRA® can cause allergic reactions that can be severe. Go to the nearest emergency room or get medical help right away if you develop any signs or symptoms of a severe allergic reaction during treatment with IMDELLTRA®, including: shortness of breath or trouble breathing, coughing, pain or tightness in your chest and back, feeling lightheaded or dizzy, wheezing, rash.

Your healthcare provider will do bloodwork before you start and during treatment with IMDELLTRA®. Your healthcare provider will monitor you for signs or symptoms of these serious side effects during treatment and may temporarily or completely stop treatment with IMDELLTRA® if you develop certain serious side effects.

  • The most common side effects of IMDELLTRA® also include:
  • tiredness
  • decreased appetite
  • a bad or metallic taste in your mouth
  • fever
  • muscle or bone pain
  • constipation
  • nausea

These are not all the possible side effects of IMDELLTRA®.

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

What is IMDELLTRA® (tarlatamab-dlle)?

IMDELLTRA® is a prescription medicine used to treat adults with extensive stage small cell lung cancer
(ES-SCLC), which is cancer that has spread throughout the lung or to other parts of the body, and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if IMDELLTRA® is safe and effective in children.

Please see IMDELLTRA® full Prescribing Information, including BOXED WARNINGS and Medication Guide.

References: 1. IMDELLTRA® (tarlatamab-dlle) prescribing information, Amgen. 2. Einsele H, et al. Cancer. 2020;126:3192–3201. 3. National Cancer Institute. NCI Dictionary of Cancer Terms. www.cancer.gov. Accessed March 2, 2026. 4. GO2 for Lung Cancer. www.go2.org. Accessed March 17, 2026. 5. Food and Drug Administration. https://www.fda.gov/. Accessed March 17, 2026. 6. IMDELLTRA® (tarlatamab-dlle) medication guide, Amgen. 7. Shimabukuro-Vornhagen A, et al. J Immunother Cancer. 2018;6:56.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMDELLTRA®?

IMDELLTRA® can cause side effects that can be severe, life-threatening or cause death, including:

Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA® and can be severe, life-