FDA: Use Risk-Based Assessments for Therapeutic Protein Products

Manufacturers and clinical investigators developing therapeutic protein products, such as monoclonal antibody cancer drugs, are urged to adopt risk-based assessments of patient immune responses that could impair drug safety and efficacy, FDA draft guidance states. Immune responses to these biologics can range from responses with no apparent clinical manifestations to life-threatening reactions. The draft urges drugmakers to maintain a “high index of suspicion” for clinical events that may originate from such responses, even if the initial risk assessment suggests a lower risk of immunogenicity.
Clinical Trials Advisor