Cejemly (sugemalimab)
- Region
- 🇪🇺 EU
- Active substance
- sugemalimab
- Company
- Cstone Pharmaceuticals Ireland Limited
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Wed 24 Jul 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006088
- ATC
- L01FF11
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Follow Cejemly
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.