Webinar; Recent FDA Oncology Initiatives

Events Main

11:00 am  – 12:00 pm  EST


Guest Speaker:
Clara Li, VP-Regulatory and Strategic Development, Caidya

This presentation will discuss two recent FDA guidance documents issued related to oncology drug development. The first is related to dose optimization for treatment of oncologic disease as part of Project Optimus which was published as draft guidance in January 2023. In this guidance, FDA discusses the issue with Maximum Tolerated Dose (MTD) approach for oncology dose selection and offers recommendations. The second subject is Tissue Agnostic drug development, issued as draft guidance in October 2022. This opens up the opportunity to develop a single treatment for multiple tumor types if they all contain the same specific molecular alteration such as biomarker or pathway.