NeoRx MoAb agent gets FDA panel's nod
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.
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
