By VETTAPHARMA reporter – Derek Roche: Amgen reported that the European Commission (EC) approved IMDYLLTRA (tarlatamab) as monotherapy for adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line platinum-based chemotherapy. The approval expands access to a novel treatment option for one of the most aggressive forms of lung cancer across the European Union.
The EC decision was supported by results from the pivotal Phase III DeLLphi-304 trial, in which IMDYLLTRA reduced the risk of death by 40% compared with standard chemotherapy. The study demonstrated a median overall survival of 13.6 months with IMDYLLTRA versus 8.3 months with chemotherapy, representing an improvement of more than five months in a disease setting where treatment options remain limited.
IMDYLLTRA is a first-in-class bispecific T-cell engager that targets delta-like ligand 3 (DLL3), a protein expressed on the surface of most small cell lung cancer cells. By simultaneously binding DLL3 on tumor cells and CD3 on T cells, the therapy is designed to redirect the immune system to attack cancer cells.
The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued earlier this year. Under the approved indication, IMDYLLTRA can be used in adults with ES-SCLC whose disease has progressed after initial platinum-based chemotherapy.
Small cell lung cancer accounts for approximately 15% of all lung cancer cases and is characterized by rapid tumor growth, early metastatic spread, and historically poor survival outcomes. Most patients are diagnosed with extensive-stage disease, and relapse following first-line treatment remains common.
The DeLLphi clinical development program has positioned IMDYLLTRA as one of the most significant advances in relapsed ES-SCLC in recent years. Earlier studies supported regulatory approvals in multiple regions, including the United States, where the therapy received full approval in 2025 following confirmation of its survival benefit.
For patients, the approval introduces a targeted immunotherapy option capable of extending survival beyond what has historically been achieved with chemotherapy alone. From a commercial perspective, the decision strengthens Amgen’s oncology portfolio and expands the global footprint of one of the company’s fastest-growing bispecific T-cell engager programs.
Quick FAQs
1. What Is IMDYLLTRA?
IMDYLLTRA (tarlatamab) is a DLL3-targeting bispecific T-cell engager immunotherapy developed by Amgen for small cell lung cancer.
2. What Did the European Commission Approve?
The EC approved IMDYLLTRA as monotherapy for adults with extensive-stage small cell lung cancer whose disease progressed following first-line platinum-based chemotherapy.
3. What Is the DeLLphi-304 Study?
DeLLphi-304 is a Phase III trial comparing IMDYLLTRA with standard chemotherapy in patients with relapsed extensive-stage small cell lung cancer.
4. What Is Extensive-Stage Small Cell Lung Cancer?
ES-SCLC is an aggressive form of lung cancer that has spread beyond the original lung and is associated with rapid progression and poor prognosis.
5. What Survival Benefit Did IMDYLLTRA Demonstrate?
The therapy reduced the risk of death by 40% and improved median overall survival from 8.3 months to 13.6 months compared with chemotherapy.
6. Why Is This Approval Important?
The approval provides a novel immunotherapy option in a disease setting with limited effective treatments and significant unmet medical need.
