EMA Recommends Imdylltra for Relapsed Small Cell Lung Cancer

EMA News

Published March 27th, 2026

Detected March 28th, 2026

Summary

The European Medicines Agency (EMA) has recommended marketing authorisation for Imdylltra (tarlatamab) for adults with relapsed extensive-stage small cell lung cancer. This recommendation is based on Phase 3 trial data showing improved overall survival and progression-free survival compared to standard of care.

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What changed

The European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Imdylltra (tarlatamab) as a new treatment for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). This recommendation follows a Phase 3 study demonstrating a significant improvement in overall survival (40% reduction in risk of death) and progression-free survival compared to standard chemotherapy. The drug is a bispecific antibody targeting DLL3 and CD3 proteins to activate T cells against tumor cells.

While Imdylltra offers a new therapeutic option for patients with limited treatment choices and poor prognosis, healthcare providers must be aware of serious potential side effects, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The product information will detail management strategies for these risks, and patients will receive a card outlining symptoms and when to seek urgent medical attention. The EMA's recommendation is an intermediate step; the European Commission will make the final decision on EU-wide marketing authorisation, after which price and reimbursement decisions will be made at the Member State level.

What to do next

Review EMA's recommendation for Imdylltra (tarlatamab) for relapsed ES-SCLC.
Familiarize with potential side effects, particularly CRS and ICANS, and their management.
Await European Commission decision on marketing authorisation.

Source document (simplified)

New treatment for relapsed extensive-stage small cell lung cancer

27 March 2026

Imdylltra addresses unmet need in people with poor prognosis and limited treatment options News Human

EMA has recommended granting a marketing authorisation in the European Union (EU) for Imdylltra (tarlatamab) as monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with platinum-based chemotherapy.

SCLC is a rare, rapidly growing cancer associated with a poor prognosis. While many patients initially benefit from treatment with platinum-based chemotherapy, relapse is common. Treatment options following relapse are limited and outcomes remain poor, highlighting the need for new treatment options. Imdylltra provides a new targeted immunotherapy approach for these patients.

Imdylltra contains the active substance tarlatamab, a bispecific antibody that acts as a T-cell engager. It binds to the DLL3 protein on tumour cells and the CD3 protein on T cells, bringing them into close proximity. This activates T cells and leads to the production of inflammatory cytokines and the release of cytotoxic proteins, resulting in tumour cell death.

EMA based its recommendation on a randomised, open-label, phase 3 study comparing treatment with Imdylltra with standard of care in 509 adults with ES-SCLC whose cancer had relapsed after an initial treatment with platinum-based chemotherapy. Participants received either Imdylltra or standard of care chemotherapy (topotecan, lurbinectedin or amrubicin). The primary endpoint was overall survival (OS) and progression-free survival (PFS) was a key secondary endpoint.

The study showed a significant improvement in median overall survival of 13.6 months in people treated with Imdylltra, compared with 8.3 months in those given standard of care. This corresponds to a 40% reduction in the risk of death in participants treated with Imdylltra. The median PFS was 4.2 months in people treated with Imdylltra, compared with 3.2 months in those given standard of care.

The most common and serious side effect with Imdylltra is cytokine release syndrome (CRS), an immune reaction caused by the rapid release of inflammatory cytokines into the bloodstream. CRS can cause symptoms such as fever, low blood pressure and breathing difficulty, and can be life-threatening. Another serious side effect is immune effector cell-associated neurotoxicity syndrome (ICANS), an immune reaction that leads to inflammation in the brain and can cause confusion and difficulty speaking and walking. Because CRS and ICANS can be serious, early recognition and treatment are important. Therefore, the product information will describe these risks and provide guidance on their management. A patient card will also be provided to all patients to inform them about the symptoms of CRS and ICANS and when to seek urgent medical attention. Other common side effects with Imdylltra include decreased appetite, fever, dysgeusia (taste disturbance), constipation, anaemia, fatigue, nausea, asthenia (weakness), neutropenia (low levels of neutrophils), hyponatraemia (low blood sodium levels), headache and lymphopenia (low levels of lymphocytes).

The opinion adopted by the CHMP is an intermediary step on Imdylltra’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role or use of this medicine in the context of the national health system of that country.

Notes:

The applicant for Imdylltra is Amgen Europe B.V.
Imdylltra was designated as an orphan medicinal product for the treatment of small cell lung cancer on 12 January 2024.
Following this positive CHMP opinion, the Committee for Orphan Medicinal Products (COMP) will assess whether the orphan designation should be maintained.
Imdylltra falls under the scope of the EU Health Technology Assessment Regulation. The Member State Coordination Group on Health Technology Assessment (HTA) will endorse the draft joint clinical assessment on this product within 30 days of the granting of the marketing authorisation. The joint clinical assessment is independent of EMA’s review of the marketing authorisation application and is coordinated by the HTA Secretariat within the European Commission.