IMDELLTRA (AMG757) Tarlatamab-dlle Kit
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other monoclonal antibodies and antibody drug conjugates class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Tarlatamab-dlle is used for treatment of advanced small cell lung cancer (SCLC). Tarlatamab-dlle is in a class of medications called bispecific T-cell engager antibodies. It works by slowing or stopping the growth of cancer cells in your body.
Read the full MedlinePlus article ↗Patient education
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9026 | $1,612.421 / J9026 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Imdelltra (Amg757)this 55513-0059-01 | Amgen, | 1 kit | — | — | FDA listed | — |
| Imdelltra (Amg757) 55513-0077-01 | Amgen, | 1 kit | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | May 16, 2036 |
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55513-0059-01 You're viewing this | 1 KIT in 1 PACKAGE (55513-059-01) * 1 mg in 1 VIAL (55513-103-01) * 7 mL in 1 VIAL (55513-068-01) | 2024-05-16 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] .
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] .
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning . Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS.
Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity. ( 2.5 , 5.1 ) Neurologic toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly.
Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity. ( 2.5 , 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer as an intravenous infusion over 1 hour. ( 2.2 ) Administer IMDELLTRA according to the step - up dosing schedule in Table 1 to reduce the risk of cytokine release syndrome. ( 2.2 ) Administer concomitant medications as recommended.
( 2.3 ) Monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration.
( 2.2 , 2.6 )
2.1Important Dosage and Administration Information Administer IMDELLTRA according to the step-up dose and schedule in Table 1 to reduce the incidence and severity of cytokine release syndrome (CRS) [see Dosage and Administration (2.2) ] . Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated [see Warnings and Precautions (5.3 , 5.5) ] .
Ensure patients are well hydrated prior to administration of IMDELLTRA [see Warnings and Precautions (5.1) ] . For Cycle 1, administer recommended concomitant medications in Table 3 before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions to reduce the risk of CRS reactions [see Dosage and Administration (2.3) ] . IMDELLTRA should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions, such as CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Warnings and Precautions (5.1 , 5.2) ] .
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting [see Dosage and Administration (2.5) and Warnings and Precautions (5.1 , 5.2) ] . Recommend patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Inform both the patient and the caregiver on the signs and symptoms of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) prior to discharge.
2.2Recommended Dosage and Administration Administer IMDELLTRA as an intravenous infusion for one hour. The recommended step-up dose and schedule for IMDELLTRA is provided in Table 1. Administer step-up dose and schedule on Cycle 1 Day 1 to reduce the incidence and severity of CRS.
After step-up dose and schedule on Cycle 1 Day 1, administer IMDELLTRA every 2 weeks until disease progression or unacceptable toxicity. Table 1. Recommended Dose and Schedule of IMDELLTRA Dosing Schedule Day Dose of IMDELLTRA Administration Instructions Recommended Monitoring Note: See Table 4 for recommendation on restarting IMDELLTRA after dose delays.
Step-up Dose and Schedule Cycle 1 Day 1 Administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3. Step-up dose 1 mg Administer IMDELLTRA as a 1-hour intravenous infusion in an appropriate healthcare setting. Monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the IMDELLTRA infusion accompanied by a caregiver. Day 8 10 mg Day 15 10 mg Observe patients for 6-8 hours post IMDELLTRA infu…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 1 mg of white to slightly yellow lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 10 mg of white to slightly yellow lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 1 mg of lyophilized powder in a single-dose vial for reconstitution and further dilution.
( 3 ) For injection: 10 mg of lyophilized powder in a single-dose vial for reconstitution and further dilution. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None . None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cytopenias : Monitor complete blood counts prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. Withhold or permanently discontinue based on severity.
( 5.3 ) Infections : Monitor for signs and symptoms of infection; treat appropriately. Withhold or permanently discontinue based on severity. ( 5.4 ) Hepatotoxicity : Monitor liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6.
More frequent evaluation may be necessary as clinically indicated. Withhold or permanently discontinue based on severity. ( 5.5 ) Hypersensitivity : Monitor for signs and symptoms of hypersensitivity and treat accordingly.
Withhold or permanently discontinue based on severity. ( 5.6 ) Embryo - Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.7 , 8.1 , 8.3 )
5.1Cytokine Release Syndrome IMDELLTRA can cause cytokine release syndrome (CRS) including life-threatening or fatal reactions. In the pooled safety population [see Adverse Reactions (6.1) ] , CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.
Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS.
Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA was 15 hours (range: start of infusion to 15 days).
Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Administer IMDELLTRA following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3 to reduce the risk of CRS [see Dosage and Administration (2.3) ] .
Administer IMDELLTRA in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA.
At the first sign of CRS, immediately discontinue IMDELLTRA infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA based on severity [see Dosage and Administration (2.5) ] . Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.
5.2Neurologic Toxicity Including ICANS IMDELLTRA can cause life-threatening or fatal neurologic toxicity including ICANS. In the pooled safety population [see Adverse Reactions (6.1) ] , neurologic toxicity occurred in 65% of patients who received IMDELLTRA, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), heada…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1) ] Neurologic Toxicity Including ICANS [see Warnings and Precautions (5.2) ] Cytopenias [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions (> 20%) were cytokine release syndrome, fatigue, decreased appetite, anemia, dysgeusia, pyrexia, constipation, musculoskeletal pain, and nausea.
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased sodium, decreased total neutrophils, and increased uric acid. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to intravenous IMDELLTRA, as a single agent, at the recommended dosage of IMDELLTRA 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304.
Among 473 patients who received IMDELLTRA, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year. The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%). The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).
Extensive Stage Small Cell Lung Cancer The safety of IMDELLTRA was evaluated in 252 patients in DeLLphi-304, a multicenter, randomized, open label trial in patients with extensive stage small cell lung cancer (ES- SCLC) with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody [see Clinical Studies (14.1) ]. Patients received IMDELLTRA (n=252) or investigator's choice or investigator's choice of topotecan [n=176], lurbinectedin [n=45] or amrubicin [n=23]. Among patients who received IMDELLTRA, 41% were exposed for 6 months or longer and 18% were exposed for greater than one year.
The demographic characteristics of patients who received IMDELLTRA were: median age 64 years (range: 20 to 86); 71% male; 60% White, 38 % Asian, 0.8% Black or African American; and 4.8% were of Hispanic or Latino ethnicity. Serious adverse reactions occurred in 52% of patients who received IMDELLTRA. Serious adverse reactions in >3% of patients included CRS (17%), pyrexia (6%), pneumonia (5%) and ICANS (3.6%).
Fatal adverse reactions occurred in 8% of patients who received IMDELLTRA, including one fatal adverse reaction of ICANS (0.4%). Fatal adverse reactions occurring in more than one patient included pneumonia (1.6%), cardio-respiratory arrest (1.6%), and sepsis (0.8%). Permanent discontinuation of IMDELLTRA due to an adverse reaction occurred in 6% of patients.
Adverse reactions which resulted in permanent discontinuation of IMDELLTRA in > 1% of patients included pneumonia (1.2%). Dosage interruptions of IMDELLTRA due to an adverse reaction occurred in 38% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included neutropenia (5%), fatigue (4.4%), pneumonia (4%), decreased appetite (2.8%), COVID-19 (2%).
Table 13…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of IMDELLTRA in pregnant women to inform a drug-associated risk. In an animal reproduction study, a murine surrogate molecule administered intravenously to pregnant mice crossed the placental barrier .
Tarlatamab-dlle causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, IMDELLTRA has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis.
The surrogate molecule crossed the placental barrier and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity.
8.2Lactation Risk Summary There are no data on the presence of tarlatamab-dlle in human milk or the effects on the breastfed child or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to IMDELLTRA are unknown.
Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with IMDELLTRA and for 2 months after the last dose.
8.3Females and Males of Reproductive Potential IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating IMDELLTRA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose.
8.4Pediatric Use The safety and effectiveness of IMDELLTRA have not been established in pediatric patients.
8.5Geriatric Use Of the 473 patients with SCLC who received IMDELLTRA 10 mg as a single agent, 51% were 65 years of age or older and 11% were 75 years of age or older. No overall differences in IMDELLTRA pharmacokinetics, safety or efficacy were observed between older patients (≥ 65 years of age) and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of IMDELLTRA in pregnant women to inform a drug-associated risk. In an animal reproduction study, a murine surrogate molecule administered intravenously to pregnant mice crossed the placental barrier .
Tarlatamab-dlle causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, IMDELLTRA has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis.
The surrogate molecule crossed the placental barrier and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of IMDELLTRA have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 473 patients with SCLC who received IMDELLTRA 10 mg as a single agent, 51% were 65 years of age or older and 11% were 75 years of age or older. No overall differences in IMDELLTRA pharmacokinetics, safety or efficacy were observed between older patients (≥ 65 years of age) and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tarlatamab-dlle is a bispecific T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle causes T-cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells. Tarlatamab-dlle had anti-tumor activity in mouse models of SCLC.
12.2Pharmacodynamics Exposure-Response Relationships There are no clinically significant exposure-response relationships for efficacy over the exposure range observed between tarlatamab-dlle 10 mg and 100 mg (10 times the highest approved recommended dosage). There is an exposure-response relationship between tarlatamab-dlle exposure and neutropenia or neurologic toxicity including ICANS with a higher risk of any grade neutropenia or neurologic toxicity including ICANS at higher exposure. Serum Cytokines Transient elevation of serum cytokines IL-2, IL-6, IL-8, IL-10, and IFN-γ were observed at a tarlatamab-dlle dosage of 0.3 mg and above.
Peak elevation of cytokines was generally observed 24 hours following the initial dose of IMDELLTRA at 1 mg on Cycle 1 Day 1 and generally returned to baseline levels prior to the next infusion on Cycle 1 Day 8.
12.3Pharmacokinetics Tarlatamab-dlle pharmacokinetic data in patients with SCLC at the approved recommended dosage are presented as mean (CV%) unless otherwise specified. The exposure of tarlatamab-dlle increases in a dose proportional manner over the dosage range of 1 mg to 100 mg (10 times the highest approved recommended dosage) every 2 weeks. Tarlatamab-dlle steady state is achieved by Cycle 2 Day 15.
Pharmacokinetic parameters are summarized for the recommended dosage of IMDELLTRA in Table 17. Table 17. Pharmacokinetic Parameters of Tarlatamab-dlle Parameter C avg (ng/mL) C max (ng/mL) C trough (ng/mL) First step-up dose 1 mg 106 (26%) 314 (35%) 49 (35%) First treatment dose 10 mg 1,100 (26%) 3,190 (35%) 517 (36%) Steady state 10 mg every 2 weeks 1,040 (37%) 3,640 (35%) 472 (62%) Distribution Tarlatamab-dlle steady state volume of distribution is
8.5L (33%). Metabolism Tarlatamab-dlle is expected to be metabolized into small peptides by catabolic pathways. Elimination Tarlatamab-dlle terminal elimination half-life is 11 days (31%) with an estimated systemic clearance of
0.7L/day (34%). Specific Populations No clinically significant differences in the pharmacokinetics of tarlatamab-dlle were observed based on age (20 to 86 years), body weight (35 to 149 kg), sex, race (68% White and 27% Asian), mild or moderate renal impairment (eGFR 30 to < 90 mL/min), or mild hepatic impairment (total bilirubin ≤ upper limit of normal (ULN) and AST > ULN). The effects of severe renal impairment (eGFR 15 to < 30 mL/min), end-stage renal disease (eGFR <15 mL/min), or moderate to severe hepatic impairment (total bilirubin > 1.5 × ULN and any AST) on the pharmacokinetics of tarlatamab-dlle are unknown.
Effects of Tarlatamab - dlle on CYP450 Substrates Tarlatamab - dlle causes transient release of cytokines that may suppress CYP450 enzymes and may result in an increased exposure of concomitant CYP substrates during and up to 14 days after occurrence of cytokine release syndrome [see Clinical Pharmacology (12.2) ] .
12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of tarlatamab-dlle or of other tarlatamab products. During the maximum 3-year treatment period during which the presence of ADA was evaluated in DeLLphi-300, DeLLphi-301, and DeLLphi-304, 8% (36/445) of patients who received the recommended step-up and full dose of IMDELLTRA developed treatment- emergent ADA.
In DeLLphi-301 and DeLLphi-304, which included neutralizing antibody assessm…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tarlatamab-dlle is a bispecific T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle causes T-cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells. Tarlatamab-dlle had anti-tumor activity in mouse models of SCLC.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied IMDELLTRA (tarlatamab-dlle) for injection is a sterile, preservative-free, white to slightly yellow, lyophilized powder supplied as follows: 1 mg package (NDC 55513-059-01) contains 1 single-dose vial of 1 mg IMDELLTRA and 2 vials of 7 mL IV Solution Stabilizer. 10 mg package (NDC 55513-077-01) contains 1 single-dose vial of 10 mg IMDELLTRA and 2 vials of 7 mL IV Solution Stabilizer.
16.2Storage and Handling Store IMDELLTRA and IV Solution Stabilizer (IVSS) vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. IMDELLTRA and IV Solution Stabilizer (IVSS) vials may be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours in the original carton to protect from light.
📦 Storage and Handling ▾
16.2Storage and Handling Store IMDELLTRA and IV Solution Stabilizer (IVSS) vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. IMDELLTRA and IV Solution Stabilizer (IVSS) vials may be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours in the original carton to protect from light.
📋 Description ▾
11 DESCRIPTION Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle is produced using recombinant DNA technology in Chinese hamster ovary cells. It consists of 982 amino acids and has a molecular weight of approximately 105 kilodaltons.
IMDELLTRA (tarlatamab-dlle) for injection is supplied as a sterile, preservative-free, white to slightly yellow, lyophilized powder in a single-dose vial for reconstitution and further dilution. Each 1 mg vial contains tarlatamab-dlle (1 mg), glutamic acid (0.72 mg), polysorbate 80 (0.04 mg), sucrose (37.1 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 1.3 mL of Sterile Water for Injection the resulting concentration is 0.9 mg/mL IMDELLTRA.
Each 10 mg vial contains tarlatamab-dlle (10 mg), glutamic acid (3.7 mg), polysorbate 80 (0.2 mg), sucrose (194.4 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 4.4 mL of Sterile Water for Injection the resulting concentration is 2.4 mg/mL IMDELLTRA. IV Solution Stabilizer is supplied as a sterile, preservative-free, colorless to slightly yellow, clear solution.
Each vial of IV Solution Stabilizer contains citric acid monohydrate (36.75 mg), lysine hydrochloride (1598.8 mg), polysorbate 80 (7 mg), sodium hydroxide to adjust pH to 7.0, and water for injection.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Cytokine Release Syndrome (CRS) Inform patients and their caregivers of the risk of CRS, and to immediately contact their healthcare provider for signs and symptoms associated with CRS including pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting [see Warnings and Precautions (5.1) ] . Advise patients that they should be monitored from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 doses in an appropriate healthcare setting [see Warnings and Precautions (5.1) ] .
Advise patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Neurologic Toxicity Including Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) Discuss the signs and symptoms associated with ICANS with patients and their caregivers. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of ICANS, such as encephalopathy, confusion, delirium, seizure, ataxia, weakness or numbness of arms and legs, tremor, and headache.
Advise patients who experience neurologic toxicity or symptoms of ICANS to refrain from driving, operating heavy or potentially dangerous machinery, and engaging in hazardous occupations or activities during treatment with IMDELLTRA [see Warnings and Precautions (5.2) ] . Cytopenias Discuss the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia with patients and their caregivers [see Warnings and Precautions (5.3) ] . Inform patients that they will need to undergo lab tests to monitor blood counts.
Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of cytopenias. Infections Discuss the signs and symptoms of infections with patients and their caregivers. Advise patients of the risk of serious infections, and to immediately contact their healthcare provider for signs or symptoms of infections [see Warnings and Precautions (5.4) ] .
Hepatotoxicity Discuss the signs and symptoms of hepatotoxicity and bilirubin with patients and their caregivers. Inform patients that they will need to undergo lab tests to monitor liver function. Advise patients to immediately contact their healthcare provider for signs and symptoms of liver dysfunction [see Warnings and Precautions (5.5) ] .
Hypersensitivity Discuss the signs and symptoms of allergic reactions with patients and their caregivers. Advise patients to immediately seek medical attention for any signs and symptoms of severe reactions [see Warnings and Precautions (5.6) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose [see Warnings and Precautions (5.7) , Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise women not to breastfeed during treatment with IMDELLTRA and for 2 months after the last dose [see Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
MEDICATION GUIDE IMDELLTRA ® (im del trah) (tarlatamab-dlle) for injection, for intravenous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2025 What is the most important information I should know about IMDELLTRA?
IMDELLTRA can cause serious side effects, including: Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA and can also 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 100.4°F (38°C) 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 on a "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. See " How will I receive IMDELLTRA? " for more information about how you will receive IMDELLTRA. 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 an appropriate healthcare setting that can manage these side effects.
You should remain within 1 hour of an appropriate 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 comple…