2019 PharmSci 360
Development of oncology compounds is commonly expedited to allow faster access to novel effective therapies. Safety and efficacy of new cancer agents are established in clinical studies that historically have excluded patients with advanced degrees of hepatic impairment, resulting in labeling that lacks dosing recommendation for these patients at the time of first approval. In this session, retrospective analysis of oncology drug approvals over the past 2 decades focusing on dosing recommendations for patients with hepatic impairment will be presented. This session will 1) identify strategies (eg, dedicated study vs population PK) associated with requests for post-marketing investigation in this patient population given the drug properties (eg, small vs large molecules); and 2) to determine the magnitude of increase in drug exposure that requires alternative dosing recommendations considering the exposure-response relationship. This session is complementary to another propose Rapid Fire that provides background and sets the stage for this talk.