Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Monday that it has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Imfinzi (durvalumab) as monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) following platinum-based chemoradiation therapy.

This recommendation is based on results from the ADRIATIC Phase III trial, which demonstrated a 27% reduction in the risk of death for Imfinzi compared to placebo. Median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo.

Progression-free survival was also improved, with Imfinzi reducing the risk of disease progression or death by 24% compared to placebo. Median progression-free survival was 16.6 months for Imfinzi versus 9.2 months for placebo.

LS-SCLC is a highly aggressive cancer with poor long-term survival rates, as only 15-30% of patients survive beyond five years. Despite initial response to treatment, recurrence and progression remain significant challenges.

The safety profile of Imfinzi was consistent with prior findings, with no new safety signals observed.

Imfinzi is already approved for this indication in the United States and several other countries. Regulatory reviews are ongoing in Japan and additional markets.