EMA — authorised 24 July 2024
- Application: EMEA/H/C/006088
- Marketing authorisation holder: Cstone Pharmaceuticals Ireland Limited
- Local brand name: Cejemly
- Indication: Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults with metastatic non small cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Cejemly (sugemalimab) on 24 July 2024. Cejemly is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) who have no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations, in combination with platinum-based chemotherapy. Additionally, Cejemly is indicated as monotherapy for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.