Shots:

• The approval is based on P-II assessing Zepzelca in 105 adults Ultragenyx with SCLC at 26 hospitals in the US and EU
• The study resulted in ORR was 35%- median response duration 5.3 mos.- as per investigator assessment using RECIST 1.1 and as per independent review committee- ORR was 30%- median response duration 5.1 months. Project Orbis conducted the review which is an initiative of the FDA Oncology Center of Excellence
• Zepzelca is an alkylating agent that binds to DNA and interferes with transcription factors and controls cancer cell growth. The product has also received the US FDA’s ODD for SCLC and priority review to this application

Ref: The US FDA | Image: Twitter