- EMA recommended EU marketing authorisation for Imdylltra (tarlatamab) as monotherapy for adults with relapsed extensive‑stage small cell lung cancer after platinum‑based chemotherapy.
- Tarlatamab is a bispecific T‑cell engager that binds DLL3 on tumour cells and CD3 on T cells to activate T cells and induce tumour cell death.
- Phase 3 (n=509) versus standard chemotherapy showed median overall survival 13.6 vs 8.3 months (≈40% reduction in risk of death) and median PFS 4.2 vs 3.2 months.
- Main serious risks are cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS), requiring early recognition and management.
Regulatory recommendation
EMA's CHMP has recommended an EU marketing authorisation for Imdylltra (tarlatamab) as monotherapy for adults with extensive‑stage small cell lung cancer that relapsed during or after platinum‑based chemotherapy; the opinion will be sent to the European Commission for a final decision and, if authorised, price and reimbursement will be decided by individual Member States.
Disease and mechanism
Extensive‑stage SCLC is aggressive and commonly relapses after first‑line platinum therapy; tarlatamab is a bispecific T‑cell engager that binds DLL3 on tumour cells and CD3 on T cells to activate T cells, induce inflammatory cytokines and cause tumour cell death.
Clinical data
A randomised, open‑label phase 3 trial (n=509) compared tarlatamab with standard chemotherapy (topotecan, lurbinectedin or amrubicin); the primary endpoint was overall survival and a key secondary endpoint was progression‑free survival; median OS was 13.6 vs 8.3 months (≈40% reduction in risk of death) and median PFS was 4.2 vs 3.2 months.
Safety and implementation
The main serious risks are cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS), which require early recognition and management; other common adverse effects include decreased appetite, fever, taste disturbance, constipation, anaemia, fatigue, nausea, neutropenia, hyponatraemia, headache and lymphopenia, and product information will provide guidance and a patient card.
