ralpancizumab (RN317) / Pfizer - LARVOL DELTA

Regulatory Experience Assessing the Carcinogenic Potential of a Monoclonal Antibody Inhibiting PCSK9, Bococizumab, Including a 2-Year Carcinogenicity Study in Rats. (PubMed, Int J Toxicol) - "Subsequently, after reviewing 6-month rat toxicity study data from another anti-PCSK9 antibody, RN317, with a similar low tumor incidence (unrelated to RN317), the U.S. FDA rescinded the bococizumab carcinogenicity study waiver and requested a full 2-year rat carcinogenicity study be conducted. The resulting 2-year carcinogenicity study demonstrated no bococizumab-related increase in tumors, confirming the weight-of-evidence evaluation and alleviating concerns regarding the carcinogenic potential. Here we report the scientific and regulatory background that led to the request for a rat carcinogenicity study, the feedback on the design of the carcinogenicity study, and the results from this study which affirmed the original weight-of-evidence assessment of low carcinogenic risk."

Journal • Preclinical • Dyslipidemia • Metabolic Disorders • Oncology

Pfizer pipeline (Pfizer Press Release) - RN317 (PF-05335810) discontinued from development for Hyperlipidemia since November 8, 2013.

Discontinued • Atherosclerosis • Dyslipidemia