NeoRx gets FDA nod for Verluma MoAb
NeoRx has become the latest monoclonal antibody developer to benefitfrom the Food and Drug Administration's increased attention towardMoAb products. The Seattle company announced last week that theFDA has issued final approval for Verluma, a small-cell
NeoRx has become the latest monoclonal antibody developer to benefitfrom the Food and Drug Administration's increased attention towardMoAb products. The Seattle company announced last week that theFDA has issued final approval for Verluma, a small-cell lung cancerimaging agent (SCAN 12/27/95).
The FDA's action triggered a $4.5 million milestone paymentto NeoRx from Du Pont Merck Pharmaceutical, the product's NorthAmerican licensee. Boehringer Ingelheim affiliate Dr. Karl ThomaeGmbH is licensed to manufacture Verluma. The agent was formerlyknown as OncoTrac.
Verluma is composed of a monoclonal antibody Fab fragment linkedto a technetium-99m tracer. Verluma is indicated to determinethe stage of disease in a small-cell lung cancer patient, whichcan affect the course of therapy.
NeoRx is developing a cancer therapy agent, Avicidin, whichuses a different formulation of the Verluma antibody to home inon cancer sites. Avicidin is in phase I/II clinical trials.