FDA panel recommends ProstaScint MoAb

Article

A Food and Drug Administration advisory committee last week votedunanimously to recommend that the agency approve Cytogen's productlicense application for ProstaScint, a monoclonal antibody-basedimaging agent for detecting prostate cancer. The FDA's

A Food and Drug Administration advisory committee last week votedunanimously to recommend that the agency approve Cytogen's productlicense application for ProstaScint, a monoclonal antibody-basedimaging agent for detecting prostate cancer. The FDA's MedicalImaging Drug Advisory Committee recommended approval for usingProstaScint in patients with prostate cancer in whom there isa high clinical suspicion of occult metastatic disease. The paneladvised that the information provided by ProstaScint be used withother diagnostic information.

Cytogen, of Princeton, NJ, is hoping that ProstaScint willexperience greater commercial success than OncoScint CR/OV, amonoclonal antibody-based agent for detecting colorectal and ovariancancer. OncoScint was launched in 1993 but has experienced slowsales since then. Cytogen believes the market potential for ProstaScintis larger than that of OncoScint: The American Cancer Societyestimates that there will be 317,000 new cases of prostate cancerin the U.S. in 1996, and 41,000 deaths from the disease.

Cytogen is looking for a marketing partner for ProstaScint,and is particularly interested in a company with experience inurology, as urologists are the physicians who will order ProstaScintscans.

Recent Videos
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Related Content
© 2025 MJH Life Sciences

All rights reserved.