FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia.

Unlabelled: On September 2, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (GO; Mylotarg; Pfizer, New York City, NY) for treatment of relapsed or refractory (R/R) CD33-positive acute myeloid leukemia (AML) in patients 2 years of age and older.

Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - a practical guide.

Phase-0 studies, including microdosing, also called Exploratory Investigational New Drug (eIND) or exploratory clinical trials, are a regulatory framework for first-in-human (FIH) trials. Common to these approaches is the use and implied safety of limited exposures to test articles. Use of sub-pharmacological doses in phase-0/microdose studies requires sensitive analytic tools such as accelerator mass spectrometer (AMS), Positron Emission Tomography (PET), and Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) to determine drug disposition.

Sigma receptor scintigraphy with N-[2-(1'-piperidinyl)ethyl]-3-(123)I-iodo-4-methoxybenzamide of patients with suspected primary breast cancer: first clinical results.

Unlabelled: The aim of this study was to investigate the potential of a new iodobenzamide, N-[2-(1'-piperidinyl)ethyl]-3-(123)I-iodo-4-methoxybenzamide (P-(123)I-MBA), to visualize primary breast tumor in humans in vivo. Tumor accumulation of benzamides is based on a preferential binding to sigma receptors that are overexpressed on breast cancer cells.

Methods: P-(123)I-MBA (148-185 MBq) was administered to 12 patients with a mammographically suspicious breast mass.