Overview
- The EMA’s medicines committee recommended EU approval of Imdylltra for adults with extensive‑stage small cell lung cancer after relapse on platinum chemotherapy.
- The decision rests on a 509‑patient phase 3 trial that showed median overall survival of 13.6 months with Imdylltra versus 8.3 months with standard chemotherapy.
- The study also found an estimated 40% lower risk of death for patients on the drug, with median progression‑free survival of 4.2 months versus 3.2 months.
- Imdylltra uses a bispecific T‑cell engager that links DLL3 on tumor cells to CD3 on T cells to trigger an immune attack, and it is given by infusion under specialist supervision.
- EMA flagged serious risks such as cytokine release syndrome and neurotoxicity, and it will require risk‑management guidance and a patient safety card as the file moves to the European Commission, orphan‑status review, and post‑authorisation HTA and national reimbursement steps.