What is Imdelltra and what is it used for?

Imdelltra (tarlatamab-dlle) is an immunotherapy for adults with extensive stage small cell lung cancer that has progressed on or after platinum-based chemotherapy. It is given as an intravenous drip in hospital.

Is Imdelltra a chemotherapy?

No. Chemotherapy kills fast-dividing cells directly, whereas Imdelltra is a bispecific T-cell engager that links the patient's own T cells to cancer cells carrying the DLL3 protein so the immune system can destroy them.

Imdelltra is developed and manufactured by Amgen Inc., a biotechnology company based in Thousand Oaks, California, USA. In the European Union it is sold under the name Imdylltra.

Is Imdelltra fully approved by the FDA?

Yes. It received accelerated approval on 16 May 2024 and full (traditional) approval on 19 November 2025, after the DeLLphi-304 trial confirmed that it helps patients live longer.

How much longer did patients live with Imdelltra in the trial?

In DeLLphi-304, median overall survival was 13.6 months with Imdelltra compared with 8.3 months with standard chemotherapy, a 40% reduction in the risk of death. Results for any individual patient can differ, so it is worth discussing what this means for you with your oncologist.

How often is Imdelltra given?

It starts with a small 1 mg dose on Day 1, then 10 mg on Day 8 and Day 15 of the first cycle, and 10 mg every 2 weeks after that. Each infusion takes about an hour.

Do I have to stay in hospital after the first doses?

You are monitored for 6 to 8 hours after the first two doses, have your vital signs checked the following day, and are asked to stay within an hour of the hospital with a caregiver for 48 hours after each of those doses. Later infusions need shorter observation, eventually about 2 hours.

What is cytokine release syndrome and how will I know if I have it?

It is a strong immune reaction that affected 57% of patients in the trials, usually mildly and mostly after the first or second dose. Fever, chills, dizziness, a racing heartbeat, breathlessness or headache are the signs to report to your care team straight away.

What are the most common side effects?

The most frequent ones were cytokine release syndrome, tiredness, loss of appetite, a change in taste, fever, constipation, muscle or bone pain and nausea. Your doctor will also check your blood counts and liver tests regularly.

Can I drive while taking Imdelltra?

Not if you have any neurological symptoms such as confusion, dizziness, tremor or weakness. The label advises avoiding driving and heavy machinery in that situation, so it's safest to arrange transport to and from your infusions, especially early on.

Is Imdelltra safe during pregnancy or breastfeeding?

No. It may harm an unborn baby, so a pregnancy test is done before starting and effective contraception is needed during treatment and for 2 months after the last dose; breastfeeding should also be avoided for that time.

How is Imdelltra supplied and stored?

It comes as a freeze-dried powder in 1 mg or 10 mg single-dose vials, packed with two vials of IV Solution Stabilizer. Both must be kept refrigerated at 2°C to 8°C in the original carton, away from light, and never frozen; they may stay at room temperature (20°C to 25°C) for up to 24 hours.

How much does Imdelltra cost in India?

The Imdelltra cost in India is not fixed, as each order is imported for a named patient. It depends on how many 1 mg and 10 mg vials your treatment needs, freight and cold-chain charges, and the exchange rate on the day of the order. Share your prescription with us and we will send a written, itemised quote.

Can I buy Imdelltra online in India?

Imdelltra is not sold by online pharmacies in India. It can only be imported on an oncologist's prescription, in the patient's name, and must reach the hospital under cold chain. You can start the request online through our enquiry form, and our team guides you through the documents and the import.

Why source Imdelltra through Named Patient Program and not an online seller?

Because a biologic like this is easily ruined by heat and impossible to check by eye. We source only from authorised manufacturer channels, with full import documentation, batch traceability and an unbroken cold chain to your hospital, so you know the medicine is genuine and has been stored correctly.

Where does this information come from?

Medical facts on this page are taken from the U.S. FDA prescribing information for Imdelltra (revised September 2026) on DailyMed and from the FDA's approval announcements of 16 May 2024 and 19 November 2025.

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Imdelltra

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Imdelltra

Generic Name (API): Tarlatamab-dlle

Dosage Form & Strength: 1 mg, 10 mg

Route: Intravenous (IV) infusion

Drug Class: Bispecific DLL3-directed CD3 T-cell engager (BiTE® molecule)

Manufacturer / Innovator:

Amgen Inc.

Regulatory Approval:

FDA (US)
EMA (marketed in the EU under the trade name Imdylltra®)
and others

Prescribing Information Resources

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Understanding Imdelltra (Tarlatamab-dlle) and Its Medical Uses

Imdelltra is a newer kind of anticancer medicine for small cell lung cancer that has come back or kept growing after platinum chemotherapy. Instead of attacking the cancer directly the way chemotherapy does, it helps the patient's own immune cells find the tumour and destroy it.

What Imdelltra Is Approved For

According to its U.S. prescribing information, Imdelltra is approved for adults with extensive stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. It is not approved for children; its safety and effectiveness in paediatric patients have not been established.

If you'd like to understand the disease itself first, including how it starts and who is most at risk, our small cell lung cancer guide explains it in plain language.

How Imdelltra Works

Most small cell lung cancer cells carry a protein on their surface called DLL3 (delta-like ligand 3). Imdelltra is a bispecific T-cell engager, which means one end of the molecule grabs DLL3 on the cancer cell and the other end grabs CD3 on a T cell, one of the body's main fighting cells. Once the two are held together, the T cell is switched on and kills the DLL3-carrying cell. This immune activation is also why the main side effect to watch for is cytokine release syndrome.

Approval History

The U.S. FDA first granted Imdelltra accelerated approval on 16 May 2024. That decision was based on the DeLLphi-301 study, where 40% of 99 patients saw their tumours shrink and the median response lasted 9.7 months. On 19 November 2025 the FDA converted this to full (traditional) approval after the confirmatory DeLLphi-304 trial showed a survival benefit. In the European Union the same medicine was authorised on 29 May 2026 under the name Imdylltra. It is made by Amgen Inc., Thousand Oaks, California, USA.

What the DeLLphi-304 Trial Showed

DeLLphi-304 compared Imdelltra with the chemotherapy doctors normally use at this stage (topotecan, lurbinectedin or amrubicin) in 509 people whose small cell lung cancer had progressed after platinum chemotherapy. Patients given Imdelltra lived a median of 13.6 months, against 8.3 months with chemotherapy, a 40% lower risk of death (hazard ratio 0.60). The time before the cancer grew again was also longer, 4.2 versus 3.2 months, and breathlessness improved more with Imdelltra at week 18.

How Imdelltra Is Given

Imdelltra is a 1-hour intravenous drip given in hospital. The first dose is deliberately small and the dose then steps up, which lowers the risk of a strong immune reaction:

Cycle 1, Day 1: 1 mg (step-up dose)
Cycle 1, Day 8 and Day 15: 10 mg
From then on: 10 mg every 2 weeks, for as long as it is working and side effects are manageable

Before the Day 1 and Day 8 doses of the first cycle, patients receive dexamethasone 8 mg through the vein within an hour of the infusion, and afterwards 1 litre of normal saline over 2 to 4 hours.

Monitoring After Each Dose

The first two doses need the closest watch. The label asks for 6 to 8 hours of monitoring in a suitable healthcare setting after the Day 1 and Day 8 infusions, a check of vital signs on Days 2 and 9, and for the patient to stay within an hour of that hospital, with a caregiver, for 48 hours after each of those two doses. Observation then gets shorter as treatment goes on:

Cycle 1 Day 15 and Cycle 2: 6 to 8 hours after the infusion
Cycles 3 and 4: 3 to 4 hours
Cycle 5 onwards: 2 hours

How It Is Supplied

Imdelltra comes as a white to slightly yellow freeze-dried (lyophilised) powder in single-dose vials of 1 mg or 10 mg. Each pack also contains two 7 mL vials of IV Solution Stabilizer, which coats the infusion bag so the medicine doesn't stick to it. The powder is mixed with sterile water and diluted by the hospital pharmacy before use.

This information is not a treatment plan. For personalised medical advice, talk to your oncologist and read the full prescribing information.

Warnings and Precautions for Imdelltra

Imdelltra carries an FDA boxed warning, the strongest kind, for cytokine release syndrome and neurological side effects. Knowing the early signs helps patients and families act quickly.
Cytokine Release Syndrome (CRS): this happens when the activated immune system releases a flood of inflammatory chemicals. In the combined safety data from 473 patients, it occurred in 57%; most cases were mild (Grade 1 in 39%), while Grade 3 was seen in 1.7% and Grade 4 in 0.2%. It usually appears after the first or second dose, with a median onset of 16 hours. Watch for fever, low blood pressure, tiredness, a fast heartbeat, headache, low oxygen, nausea and vomiting, and contact the treating team immediately if any appear.
Neurological Side Effects, Including ICANS: Some kind of neurological side effect was reported in 65% of patients, most often a change in taste (34%), headache, nerve tingling, dizziness and trouble sleeping. A more serious condition called ICANS (immune effector cell-associated neurotoxicity syndrome) was seen in about 10% and can show up as confusion, difficulty speaking, weakness, tremor or seizures, sometimes weeks after a dose. Anyone who has these symptoms should not drive or operate heavy machinery during treatment.
Low Blood Counts: Imdelltra can lower white cells, platelets and haemoglobin. Blood counts are checked before treatment and as needed during it, and doses may be delayed if counts fall too far.
Infections: Infections were reported in 43% of patients (14% severe), most commonly pneumonia and urinary tract infections. Fever, chills or a new cough during treatment should be reported promptly.
Liver Effects: Liver enzymes rose in roughly 4 in 10 patients, occasionally to severe levels. Liver tests and bilirubin are checked before starting and during treatment.
Allergic Reactions: Severe hypersensitivity reactions, such as rash or tightening of the airways, can occur. Patients are watched during the infusion so these can be treated straight away.
Pregnancy and Breastfeeding: Imdelltra may harm an unborn baby. A pregnancy test is done before starting, women who could become pregnant should use effective contraception during treatment and for 2 months after the last dose, and breastfeeding is not advised for the same period.
Most Common Side Effects: Across the clinical trials, the side effects seen in at least 1 in 5 patients were CRS (57%), fatigue (48%), loss of appetite (38%), taste changes (34%), fever (33%), constipation (31%), muscle and bone pain (31%) and nausea (25%).

How to Access Imdelltra in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Imdelltra

Imdelltra (Tarlatamab) Price in India: What Decides the Cost

There is no fixed Imdelltra price in India, because the medicine is not sold here and is imported separately for each patient. The final cost depends on a few clear factors:

Strength and number of vials: Imdelltra comes in 1 mg and 10 mg single-dose vials. The first cycle uses one 1 mg dose (Day 1) and two 10 mg doses (Day 8 and Day 15); after that, one 10 mg dose is given every 2 weeks.
Import and cold chain: the vials must stay at 2°C to 8°C all the way from the source country to your hospital, so freight, customs and cold-chain packing are part of the cost.
Source country and exchange rate: the supplier price is in foreign currency, so the rupee rate on the day of the order matters.
Hospital charges: the infusion, the monitoring after the first doses and blood tests are billed by your hospital, separately from the medicine.

Once we receive your oncologist's prescription, we send a written, itemised quotation so you know the full Imdelltra cost before you decide.

What documents are required to import IMDELLTRA to India?

IMDELLTRA (tarlatamab-dlle) injection may be imported in the patient's name only, by patients or government hospitals. The following documentation is required:

A valid prescription from a qualified medical oncologist
The patient's diagnostic reports (histopathology confirming small cell lung cancer, staging, and details of prior platinum-based chemotherapy)
Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is IMDELLTRA available in India?

IMDELLTRA (tarlatamab-dlle injection) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, IMDELLTRA is not commercially marketed in India.

However, patients in India can legally access IMDELLTRA through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

NamedPatientProgram.com (NPP) acts as a facilitator under named patient supply, providing input on:

Availability of Imdelltra in India and pathways to access it
Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE)
Imdelltra price in India under the NPP route
Sourcing from genuine, reliable channels in the USA, Europe, China, Singapore, Canada, and Australia
Ensuring full transparency throughout the process

IMDELLTRA can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only upon receipt of a valid doctor's prescription and, where applicable, an import permit.

Sourcing and Delivery of Imdelltra

NamedPatientProgram.com (NPP) can source Imdelltra from reliable global manufacturers and qualified pharmaceutical supply channels and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. As a temperature-sensitive biologic, Imdelltra requires cold-chain handling throughout transit.

All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For Imdelltra cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Patients across India can access Imdelltra® through regulated import pathways, with delivery arranged to the treating hospital based on a valid oncologist's prescription.

Mumbai

A major oncology and thoracic cancer hub with institutions like Tata Memorial, Mumbai, sees high demand for advanced lung cancer therapies like Imdelltra®. Access is often coordinated for patients with relapsed small cell lung cancer.

Bangalore

With a growing network of multispecialty hospitals, Bangalore supports access to global oncology treatments through structured import pathways guided by treating specialists.

Delhi

As part of the Delhi NCR region, the city has a strong concentration of cancer centers and thoracic oncology specialists, making it a key location for accessing advanced imported therapies.

Gurgaon

Home to leading hospitals like Medanta, Gurgaon plays an important role in facilitating access to innovative lung cancer treatments through coordinated care pathways.

Noida

With proximity to Delhi and access to top hospitals, Noida patients benefit from streamlined logistics and specialist-driven treatment planning.

Hyderabad

Hyderabad's advanced healthcare infrastructure and oncology expertise support patients seeking access to internationally approved cancer therapies.

Chennai

Known for its established medical ecosystem, Chennai attracts patients from across India for complex lung cancer treatments and specialized drug access.

Kolkata

A key eastern healthcare hub, Kolkata offers access to advanced oncology care through leading hospitals and treatment centers.

Ahmedabad

Ahmedabad's expanding healthcare sector and oncology facilities support patients requiring advanced and imported cancer therapies.

Pune

With reputed hospitals and a growing cancer care infrastructure, Pune is an emerging center for access to specialized oncology treatments.

Chandigarh

Serving North India, Chandigarh provides access to advanced medical care through reputed institutions and specialist-led treatment planning.

Jaipur

Jaipur's improving healthcare network enables patients to explore access to innovative cancer therapies through structured import processes.

Lucknow

As a major city in North India, Lucknow supports access to advanced oncology treatments through both public and private healthcare institutions.

Indore

Indore is emerging as a regional healthcare hub, offering access to specialized cancer care and modern treatment pathways.

Bhopal

Patients in Bhopal can access advanced cancer treatments through the growing healthcare infrastructure and referral networks.

Nagpur

Nagpur serves as a central hub for patients across Vidarbha, with increasing access to oncology care and specialized therapies.

Surat

Surat's developing healthcare ecosystem supports patients seeking access to global oncology treatments through coordinated care.

Patna

As a major city in Eastern India, Patna provides growing access to cancer treatment through expanding hospital networks.

Coimbatore

Coimbatore is known for quality healthcare services, offering access to advanced oncology treatments in South India.

Kochi

With modern hospitals and specialist care, Kochi enables patients to explore access to internationally approved cancer therapies.

Note: Access timelines may vary depending on documentation, regulatory approvals, and sourcing logistics.

Access/Buy Imdelltra® at Leading Hospitals in India

Imdelltra® is typically used in advanced thoracic oncology settings and can be accessed at leading hospitals across India, where specialists guide treatment decisions and coordinate patient-specific access pathways.

Major Hospitals Covered

Tata Memorial Centre

One of India's premier cancer institutes, Tata Memorial plays a key role in treating complex lung cancer cases and guiding patients toward advanced therapies like Imdelltra®.

AIIMS

As a leading government medical institution, AIIMS provides comprehensive cancer care and supports patients requiring access to specialized and emerging treatments.

Apollo Hospitals

With a nationwide presence, Apollo Hospitals offers advanced oncology services and facilitates access to global treatment options through its extensive medical network.

Fortis Healthcare

Fortis hospitals are equipped with modern cancer care facilities and multidisciplinary teams that manage complex treatment pathways for patients.

Max Healthcare

Max Healthcare is known for its strong oncology and pulmonology departments, providing access to innovative therapies under expert clinical supervision.

Manipal Hospitals

Manipal Hospitals supports advanced cancer care through experienced specialists and structured treatment planning across multiple cities.

Kokilaben Dhirubhai Ambani Hospital

A leading private hospital in Mumbai, Kokilaben Hospital offers cutting-edge oncology care and access to advanced global therapies.

Medanta – The Medicity

Medanta is a renowned super-specialty hospital where complex lung cancer cases are managed with advanced treatment protocols and global access support.

BLK-Max Super Speciality Hospital

BLK-Max provides comprehensive oncology services and supports patients seeking access to specialized treatment options.

Rajiv Gandhi Cancer Institute

A dedicated cancer care center, RGCI focuses on advanced oncology treatments and supports patients through complex treatment journeys.

HCG Cancer Centre

HCG is a specialized cancer hospital network known for its focus on precision oncology and advanced treatment modalities.

Narayana Health

Narayana Health combines affordability with advanced medical care, offering oncology services across multiple locations in India.

Amrita Hospital

Amrita Hospital provides high-quality cancer care with a focus on patient-centric treatment and access to modern therapies.

Yashoda Hospitals

Yashoda Hospitals are known for their strong oncology departments and advanced treatment infrastructure in South India.

Sir Ganga Ram Hospital

A well-established hospital in Delhi, Sir Ganga Ram provides multidisciplinary cancer care supported by experienced specialists.

CARE Hospitals

CARE Hospitals provide modern oncology treatment facilities and multidisciplinary care across multiple cities.

Note: Imdelltra® is not stocked for direct purchase but is arranged through compliant import processes and delivered to the hospital for patient-specific treatment.