What is it prescribed for?
IMDELLTRA, approved on May 16, 2024, 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.
What is the name of the drug and what does it do?
Imdelltra (pronounced im-DEL-trah), (generic name: tarlatamab-dlle), is a medication indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression on or after platinum-based chemotherapy.
How does it work?
Imdelltra is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager. It works by binding to DLL3 on the surface of tumor cells and CD3 on T-cells, a type of immune cell.
This binding activates T-cells to attack and destroy the DLL3-expressing tumor cells, thereby helping to manage and reduce the cancer.
What did the research discover?
Clinical trials have shown that Imdelltra is effective in treating ES-SCLC, leading to an overall response rate and a notable duration of response.
The studies indicated that a significant percentage of patients responded positively to the treatment, with many showing reduced tumor size and prolonged periods without disease progression.
The results from these trials were promising enough to gain accelerated approval based on the overall response rate and duration of response.
What are some of the side effects?
- Cytokine release syndrome (CRS)
- Fatigue
- Pyrexia (fever)
- Dysgeusia (altered taste)
- Decreased appetite
- Musculoskeletal pain
- Constipation
- Anemia
- Nausea
What are the dosage recommendations and how is it prescribed?
Imdelltra is administered as an intravenous infusion over one hour. The recommended dosage schedule involves a step-up dosing to mitigate the risk of cytokine release syndrome (CRS).
It starts with an initial low dose on Cycle 1 Day 1, followed by higher doses on subsequent days. Patients are closely monitored during the infusion and for 22 to 24 hours post-infusion on the first and eighth days of Cycle 1.
After the step-up dosing, Imdelltra is administered biweekly until disease progression or unacceptable toxicity.
Source:
- Amgen Inc. Imdelltra (tarlatamab-dlle) for injection, for intravenous use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf
