Cejemly(sugemalimab)

Cejemly (sugemalimab) is a drug for which a marketing authorization application was submitted on 4 February 2023, receiving a CHMP positive opinion on 30 May 2024. The application for Cejemly was deemed approvable. The proposed shelf life for the active substance is 24 months, and for the unopened finished product, it is 30 months. The ATC code for sugemalimab is L01FF11.

In efficacy trials, sugemalimab + chemotherapy demonstrated a median progression-free survival (PFS) of 9.03 months compared to 4.90 months for placebo + chemotherapy, with a PFS hazard ratio of 0.48. The 12-month PFS rate was 36.4% for sugemalimab + chemotherapy versus 14.8% for placebo + chemotherapy. Median overall survival (OS) was 25.43 months for sugemalimab + chemotherapy compared to 16.85 months for placebo + chemotherapy, with an OS hazard ratio of 0.65. The 24-month OS rate was 51.7% for sugemalimab + chemotherapy.

Regarding safety, Grade 3-5 treatment-emergent adverse events (TEAEs) occurred in 64.7% of patients receiving sugemalimab, compared to 62.3% in the control group. Serious adverse events (SAE) were reported in 34.4% of patients, and discontinuations of any drug due to TEAEs occurred in 19.4% of patients. Deaths due to adverse events were observed in 6.3% of patients.