- The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting.
- The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy.
- The application has also been granted Priority Review.
- Related: AstraZeneca's Stock Gain After Enhertu Meets Primary Endpoint In HER2-Low Breast Cancer Setting.
- The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022.
- The sBLA is based on data from the registrational DESTINY-Lung01 Phase 2 trial.
- Preliminary results demonstrated a confirmed objective response rate of 54.9% in patients treated with Enhertu (6.4mg/kg). One (1.1%) complete response and 49 (53.8%) partial responses were observed.
- A confirmed disease control rate of 92.3% was seen, with a reduction in tumor size observed in most patients.
- The median duration of response for Enhertu was 9.3 months. The median progression-free survival was 8.2 months, and the median overall survival was 17.8 months.
- Price Action: AZN shares are up 0.17% at $68.73 during the premarket session on the last check Tuesday.
