Imdelltra is a brand-name intravenous (IV) infusion prescribed for small cell lung cancer in certain situations. Imdelltra contains the active ingredient tarlatamab-dlle and is a type of immunotherapy.

Imdelltra is FDA approved to treat extensive stage small cell lung cancer in adults in certain situations. (“Extensive” means the cancer has spread through the lungs, to nearby lymph nodes, or to other parts of the body.) For this use, the cancer must have worsened during or after treatment with platinum-based chemotherapy.

Drug details

Here is key information about Imdelltra:

  • Drug class: bispecific DLL3-directed CD3 T-cell engager, which is a type of immunotherapy
  • Drug form: powder that is mixed with liquid to form a solution for intravenous (IV) infusion
  • Generic or biosimilar available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2024
  • Accelerated approval? yes

Imdelltra has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Imdelltra precautions” section.

Imdelltra is a biologic drug that contains the active ingredient tarlatamab-dlle. It’s only available as a brand-name medication. (The “-dlle” at the end of the drug’s name indicates that it’s distinct from similar medications that may be created in the future.)

Imdelltra isn’t available in biosimilar form. Traditional drugs are made using chemicals. They have generics that are exact copies of the active drug in the brand-name form. However, biologics are made using parts of living cells. Instead of generics, biologics have biosimilars because they cannot be copied exactly.

Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug.

As with all medications, the cost of Imdelltra can vary. The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance: If you need financial support to pay for Imdelltra, or help understanding your insurance coverage, help is available.

A program called Amgen SupportPlus is available for Imdelltra. For more information and to find out whether you’re eligible for support, call 866-264-2778 or visit the program website.

Biosimilar version: Imdelltra is a biologic drug that is not available in a biosimilar form. While traditional drugs are made using chemicals, biologics are made using parts of living cells. Traditional drugs have generic forms that are exact copies of the active drug in the brand-name form. However, biologics have biosimilars because they cannot be copied exactly.

Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug. And they may cost less than brand-name drugs.

To learn more about saving money on prescriptions, check out this article.

The following information describes Imdelltra dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug form and strengths

Imdelltra comes as a powder inside single-use vials. The powder is mixed with a liquid to form a solution that’s given as an intravenous (IV) infusion.

Imdelltra comes in two strengths: 1 milligram (mg) and 10 mg.

Dosage for small cell lung cancer

Imdelltra is prescribed to treat small cell lung cancer (SCLC) in adults in certain situations. To learn more, see the “Imdelltra uses” section.

For SCLC, you’ll typically start with step-up doses of Imdelltra. This means you’ll receive two doses of the drug to determine how your body responds to it before receiving the first treatment dose.

The usual step-up dosing schedule for Imdelltra is 1 mg on the first day, followed by 10 mg on day 8. You’ll receive the first treatment dose of 10 mg on day 15. After that, you’ll continue to receive 10 mg of Imdelltra once every 2 weeks.

How it’s given

A healthcare professional will administer Imdelltra as an IV infusion. Imdelltra infusions are typically given over 1 hour.

You’ll receive Imdelltra in a hospital, clinic, or infusion center. After your first several doses, you’ll likely stay in the facility where you received the drug for a few hours or days. This allows your doctor to monitor you closely for serious side effects.* They’ll recommend how long to stay in the facility.

If you have questions about receiving Imdelltra, talk with your doctor.

* Imdelltra has boxed warnings for certain serious side effects. A boxed warning is the most serious warning from the Food and Drug Administration. To learn more, see the “Imdelltra precautions” section.

About receiving Imdelltra

Here, you’ll find information about key dosage issues:

  • When it’s given: The first three doses of Imdelltra are given on treatment days 1, 8, and 15. After that, you’ll receive one infusion of Imdelltra every 2 weeks.
  • If you miss a dose: If you miss an appointment for your Imdelltra infusion, call your doctor’s office right away to reschedule.
  • Length of treatment: Imdelltra may be used as a long-term treatment. The length of time you’ll receive the drug depends on any side effects you have and whether your condition is improving. If you and your doctor determine that Imdelltra is safe and effective for you, you’ll likely receive it long term.
  • Length of time to work: Imdelltra starts to work after your first dose. Your doctor will monitor your condition during treatment to check whether the drug is working.

The Food and Drug Administration (FDA) approves prescription drugs such as Imdelltra to treat certain conditions.

Imdelltra for small cell lung cancer

Imdelltra is FDA approved to treat extensive stage small cell lung cancer (SCLC) in adults in certain situations. SCLC is a fast-growing type of lung cancer. “Extensive” means the SCLC has spread to the lungs, nearby lymph nodes, or other parts of the body.

For this use, the SCLC must have worsened during or after treatment with platinum-based chemotherapy, such as carboplatin or cisplatin.

You can learn more about SCLC by visiting our lung cancer hub.

Imdelltra and children

Imdelltra is not FDA approved for use in children. It’s not known for certain whether the drug is safe or effective for children.

Imdelltra can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Imdelltra. These lists do not include all possible side effects.

For more information about the possible side effects of Imdelltra, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Imdelltra, you can do so through MedWatch.

Mild side effects

Here is a partial list of mild side effects of Imdelltra. To learn about other mild side effects, talk with your doctor or pharmacist, or view Imdelltra’s prescribing information.

Mild side effects of Imdelltra can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Imdelltra aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* Imdelltra has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Imdelltra precautions” section.

ALLERGIC REACTION

For some people, Imdelltra can cause an allergic reaction. But this side effect wasn’t reported in the drug’s clinical trials.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Imdelltra, your doctor may recommend taking a different medication instead.

Imdelltra is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer of Imdelltra didn’t look at interactions in clinical trials.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Imdelltra.

Before starting Imdelltra treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Other drugs are available that can treat extensive stage small cell lung cancer. Some may be a better fit for you than others. If you’re interested in finding an alternative to Imdelltra, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are possible alternatives to Imdelltra:

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Imdelltra and pregnancy

You should not receive Imdelltra treatment during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting treatment with Imdelltra.

Your doctor may suggest birth control options to help prevent pregnancy during treatment with Imdelltra. They’ll likely advise you to use birth control while receiving the drug and for at least 2 months after your final dose.

Imdelltra and breastfeeding

You should not receive Imdelltra treatment while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before starting treatment with Imdelltra.

Your doctor may recommend other ways to feed your child during treatment with Imdelltra. They’ll likely advise you not to breastfeed while receiving the drug and for at least 2 months after your final dose.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Risk of neurologic toxicity

Imdelltra may cause neurologic toxicity. This means the drug may damage your nervous system, which includes your spinal cord and brain.

Mild neurologic toxicity was common in Imdelltra’s clinical trials. With mild toxicity, you may have symptoms such as dizziness, headache, and muscle weakness.

Severe neurologic toxicity was less common in Imdelltra’s trials. This includes a potentially life threatening condition called immune effector cell-associated neurotoxicity syndrome (ICANS). Symptoms of ICANS or other severe neurologic toxicities may include:

  • extreme drowsiness
  • feeling confused or disoriented
  • loss of consciousness
  • slowed thinking

Due to this risk, Imdelltra is only given in a healthcare facility. You’ll likely stay in the facility for a few hours or days after your first several doses of the drug. This allows your doctor to closely monitor you for neurologic toxicity or other serious side effects from the drug. Your doctor will recommend how long to stay in the facility.

If you have symptoms of neurologic toxicity, it’s important to avoid driving or other activities that require alertness until your symptoms have resolved. This is because neurologic toxicity can affect memory and coordination.

Tell your doctor right away if you have symptoms of neurologic toxicity after Imdelltra infusions. They’ll likely pause your Imdelltra treatment and treat this condition right away. Your doctor will recommend whether it’s safe to resume treatment with Imdelltra.

Risk of cytokine release syndrome

Imdelltra may cause cytokine release syndrome (CRS). This means the drug may cause certain proteins to be rapidly released into your blood, leading to an overactive immune system.

Mild CRS was common in Imdelltra’s clinical trials. With mild CRS, you may have symptoms such as nausea, headache, and fatigue.

Severe CRS was less common in Imdelltra’s trials. However, this condition can lead to life threatening problems, including:

Due to this risk, Imdelltra is only given in a healthcare facility. After your first several doses of Imdelltra, you’ll likely stay in the facility for a few hours or days. This allows your doctor to closely monitor you for CRS or other serious side effects from the drug. Your doctor will recommend how long to stay in the facility.

To help reduce your risk of CRS, your doctor may prescribe dexamethasone (Hemady) along with Imdelltra.

If you have symptoms of CRS after receiving Imdelltra infusions, tell your doctor right away. They’ll likely pause your Imdelltra treatment and treat CRS right away. Your doctor will advise you on whether it’s safe to continue treatment with Imdelltra.

Other precautions

Before taking Imdelltra, discuss your health history with your doctor. Imdelltra may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Imdelltra, see the “Imdelltra side effects” section.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.