FDA grants AZ priority review for patients with SCLC

AstraZeneca has revealed that the US FDA has granted priority review for Imfinzi (durvalumab), for the treatment of patients with previously untreated extensive stage small cell lung cancer (SCLC), and approved a supplemental Biologics License Application (sBLA).

The sBLA’s approval was based on constructive results from the Phase III CASPIAN trail which revealed considerable and meaningful improvements in overall survival versus standard of care, demonstrated through the fusion of SoC chemotherapy and Imfinzi. There was a 27% reduction in the risk of death, with an average OS of 10.3 months for SoC versus 13 months for Imfinzi plus chemotherapy. Approximately 33.9% of patients were alive eighteen months after receiving Imfinzi plus chemotherapy, in comparison to 24.7% of patients who received SoC.