Sugemalimab

Sugemalimab (Cejemly, Cstone Pharmaceuticals Ireland Limited) has 2 EU-approved indications in 1 tumour type. 1 needs a biomarker result: PD-L1 (1).
Approved indications of Sugemalimab
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
No sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations
+ platinum-based chemotherapy
1L
metastatic
None
PD-L1 expression ≥ 1%, EGFR/ALK/ROS1-negative
Monotherapy
Consol.
locally adv.
After platinum-based chemoradiotherapy without progression
Full text of section 4.1 (therapeutic indications)

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.

Label history

8 changes to the Cejemly label since 2024, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes