NeoRx MoAb agent gets FDA panel's nod

December 27, 1995

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.