Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer - AstraZeneca (NASDAQ:AZN), AstraZeneca (OTC:AZNCF), Daiichi Sankyo Co (OTC:DSNKY), Daiichi Sankyo Co (OTC:DSKYF)

The FDA has accepted for review AstraZeneca plc AZN - Daiichi Sankyo's 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.