Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer

Initial US Approval:

2024

Key Clinical Studies:

DeLLphi-304 (NCT05740566)

Drug Class/Description:

Bispecific delta-like ligand 3 (DLL3)-directed CD3 Tcell engager

Indications and Usage:

IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 Tcell 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.

Dosage and Administration:

Administer as an intravenous infusion over 1 hour.

• Administer IMDELLTRA according to the step-up dosing schedule in Table 1 to reduce the risk of cytokine release syndrome.
• Administer concomitant medications as recommended.
• 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.
• See Full Prescribing Information for instructions on preparation and administration. 

Dosage Forms and Strengths:

• For injection: 1 mg of lyophilized powder in a single-dose vial for reconstitution and further dilution. 
• For injection: 10 mg of lyophilized powder in a single-dose vial for reconstitution and further dilution.

Contraindications:

None.

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.
• Infections: Monitor for signs and symptoms of infection; treat appropriately. Withhold or permanently discontinue based on severity.
• 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.
• Hypersensitivity: Monitor for signs and symptoms of hypersensitivity and treat accordingly. Withhold or permanently discontinue based on severity.
• Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception 

Adverse Reactions:

• 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. 

Use in Specific Populations:

Lactation: Advise not to breastfeed. 

Adapted From:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761344s001lbl.pdf

 

Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.