SBRBPAS Expert Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
Immune checkpoint inhibitors (ICIs) are becoming a new standard-of-care across many cancer types. Currently, the US Food and Drug Administration (FDA) has approved nine ICIs, exclusively monoclonal antibodies targeting CTLA4, PD1, PD-L1 or LAG3. Due to the inherent tumor heterogeneity, however, only a subset of patients is expected to achieve a durable response to ICI treatment. As a result, ICIs are often co-developed with companion diagnostics (CDx) that measure the status of specific biomarkers in individual patients, aiding in the enrichment of a patient population for clinical trials to enable personalized therapy. This talk provides an update on current FDA approved ICIs and respective CDx along with an overview of the regulatory pathways for biomarker qualification. The information is further discussed with strategies for identifying biomarkers to guide clinical use of ICIs alone or in combination with chemotherapy.
Learning Objectives:
Upon completion, participants will understand the current state of FDA approved immune checkpoint inhibitors (ICIs) and companion diagnostics (CDx).
Upon completion, participants will understand the regulatory pathways for biomarker qualification.
Upon completion, participants will understand the challenges in discovery and validation of predictive biomarkers in oncology.
Upon completion, participants will understand the scientific considerations in the co-development of ICIs and CDx.
