FDA approves Imfinzi as first immunotherapy for limited-stage small cell lung cancer
The U.S. Food and Drug Administration (FDA) has approved AstraZeneca's Imfinzi as a treatment for limited-stage small cell lung cancer (LS-SCLC), marking a significant advancement in immunotherapy for the disease.
AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. This approval marks the first and only immunotherapy regimen specifically for this patient population.
The FDA's decision was based on findings from the Phase III ADRIATIC trial, which demonstrated a 27% reduction in the risk of death compared to placebo. Patients treated with Imfinzi showed a median overall survival of 55.9 months, compared to 33.4 months for those receiving placebo.
Furthermore, the trial indicated that 57% of patients treated with Imfinzi survived at three years, versus 48% in the placebo group. The treatment also showed a 24% reduction in the risk of disease progression or death. AstraZeneca highlighted that Imfinzi is now approved for both limited and extensive-stage SCLC in the US.
Regulatory applications for Imfinzi in this LS-SCLC indication are also under review in the EU, Japan, and several other countries. The company aims to improve survival rates for patients with this aggressive form of lung cancer.