The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab.

The accelerated approval (AA) pathway was established by the United States Food and Drug Administration (FDA) to provide earlier access to therapies for patients with serious medical conditions and unmet medical needs. Since its inception, the AA pathway has been used for novel treatments across different therapeutic areas, but most prominently in oncology, including the immune checkpoint inhibitor class. This review article describes the history of regulatory approvals for pembrolizumab, an immunotherapy agent targeting programmed death receptor-1 (PD-1), and use of the AA pathway and the corresponding regulatory decisions made by the FDA.

Relative frequency of dentigerous cyst in Iranian population: A 20-year retrospective study.

Purpose: Dentigerous cyst (DC) is the most common type of developmental odontogenic cysts which apparently develops via accumulation of fluid between the reduced enamel epithelium and crown of the tooth. The aim of this study is to analyze the frequency of DC in Iranian population.

Materials And Methods: The files of oral pathology, Shahid Beheshti University of Medical Sciences, served as the source of the materials from 1992 to 2012 for this study.

Comparison of insulin lispro with regular human insulin for the treatment of type 1 diabetes in adolescents.

Background: Although insulin lispro (insulin LP) has been shown to improve postprandial blood glucose (BG) control and reduce hypoglycemic episodes in adult patients with type I diabetes, there appear to have been few clinical studies focusing on its use in adolescents.

Objective: This study compared the effects of insulin LP with those of regular human insulin (insulin R) on postprandial BG control and hypoglycemia in adolescents with type diabetes.

Methods: In this crossover, open-label study, adolescents between the ages of 9 and 18 years who had reached Tanner stage II puberty were randomized to receive either insulin LP immediately before meals or insulin R 30 to 45 minutes before meals, in addition to daily intermediate-acting insulin.

Insulin lispro lowers postprandial glucose in prepubertal children with diabetes.

Objective: This study compared the glucose-lowering effect of insulin lispro, given before or after meals, with regular human insulin given before meals in prepubertal children with diabetes.

Research Design And Methods: A 3-way crossover, open-label study involving 61 prepubertal children (ages 2.9-11.

Safety of insulin lispro: pooled data from clinical trials.

The safety of insulin lispro was compared with that of regular human insulin of recombinant DNA origin (Humulin R, Lilly), with special emphasis on the development and progression of the chronic complications of diabetes mellitus in relation to insulin therapy. Ten clinical trials of 3634 patients with type 1 and type 2 diabetes mellitus were analyzed. The primary focus was treatment-emergent adverse events, and the secondary focus was the development and progression of the chronic complications of diabetes.