• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

NeoRx MoAb agent gets FDA panel's nod

Article

A monoclonal antibody imaging agent under development by NeoRxcleared a major hurdle this month when a Food and Drug Administrationadvisory committee recommended the product for approval. The panel'smove puts NeoRx's Verluma, formerly known as OncoTrac,

A monoclonal antibody imaging agent under development by NeoRxcleared a major hurdle this month when a Food and Drug Administrationadvisory committee recommended the product for approval. The panel'smove puts NeoRx's Verluma, formerly known as OncoTrac, into positionto be the second monoclonal antibody-based imaging agent to reachthe market, after Cytogen's OncoScint CR/OV.

The FDA's Oncologic Drugs Advisory Committee recommended thatVerluma's product license application (PLA) be approved for theinitial staging of patients with biopsy-confirmed small-cell lungcancer. NeoRx hopes that Verluma, a technetium-labeled monoclonalantibody fragment, will prove cheaper and more useful than traditionalbatteries of tests for small-cell lung cancer, such as CT andbone scans. NeoRx representatives also say Verluma has a lowerHAMA (human anti-mouse antibody) response rate than other monoclonalantibody agents.

Seattle-based NeoRx has licensed North American rights forVerluma to Du Pont Merck Pharmaceutical (SCAN 10/26/94). BoehringerIngelheim manufactures Verluma for NeoRx.

Related Videos
Where the USPSTF Breast Cancer Screening Recommendations Fall Short: An Interview with Stacy Smith-Foley, MD
A Closer Look at MRI-Guided Transurethral Ultrasound Ablation for Intermediate Risk Prostate Cancer
Improving the Quality of Breast MRI Acquisition and Processing
Can Fiber Optic RealShape (FORS) Technology Provide a Viable Alternative to X-Rays for Aortic Procedures?
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Can Diffusion Microstructural Imaging Provide Insights into Long Covid Beyond Conventional MRI?
Assessing the Impact of Radiology Workforce Shortages in Rural Communities
Emerging MRI and PET Research Reveals Link Between Visceral Abdominal Fat and Early Signs of Alzheimer’s Disease
Reimbursement Challenges in Radiology: An Interview with Richard Heller, MD
Related Content
© 2024 MJH Life Sciences

All rights reserved.