The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The decision follows the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) endorsement last month.
Phase II Data Analysis
The approval is supported by Phase II data analysis, which demonstrated that Enhertu achieved confirmed objective response (ORR) and partial response (PR) rates of 49.0% and 48%, respectively. Additionally, the median duration of response (DOR) was 16.8 months, highlighting the drug’s efficacy in treating this aggressive form of lung cancer.
Financial Implications
The approval triggers a significant financial milestone for Daiichi Sankyo, enabling the company to receive a USD 75 million payment from AstraZeneca as per their 2019 collaboration agreement. This milestone payment underscores the value of Enhertu in the oncology market and the collaborative efforts between the two pharmaceutical giants.-Fineline Info & Tech
