Imdelltra FDA Approval History
Last updated by Judith Stewart, BPharm on May 20, 2024.
FDA Approved: Yes (First approved May 16, 2024)
Brand name: Imdelltra
Generic name: tarlatamab-dlle
Dosage form: for Injection
Company: Amgen Inc.
Treatment for: Small Cell Lung Cancer
Imdelltra (tarlatamab-dlle) is a first-in-class, 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.
- Imdelltra received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Small cell lung cancer (SCLC) is an aggressive form of lung cancer that is strongly associated with cigarette smoking.
- DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells. Imdelltra is a targeted therapy that works by binding to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.
- FDA accelerated approval of Imdelltra was based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. Results from the study found that Imdelltra at the 10 mg Q2W dose (N=99) demonstrated a robust objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.
- Imdelltra is administered as an intravenous infusion over 1-hour.
- Imdelltra comes with a Boxed Waring for cytokine release syndrome and neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Warnings and precautions associated with Imdelltra include cytopenias, hepatotoxicity, hypersensitivity reactions, and embryo-fetal toxicity.
- Common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.
Common Grade 3 or 4 laboratory abnormalities include decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, decreased potassium, increased aspartate aminotransferase, decreased white blood cells, decreased platelets, and increased alanine aminotransferase.
Development timeline for Imdelltra
Further information
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