NeoRx Corp.'s imaging agent for small cell lung cancerwas recommended for approval by an FDA advisorycommittee.
The 9-4 advisory committee vote was forrecommendation of Verluma for initial staging of patientswith biopsy-confirmed small cell lung cancer (SCLC).The product is composed of a monoclonal antibodyfragment linked to technetium-99. It targets tumor tissuesthat express a specific antigen.
"One of the important parts of this approval process isthat we've demonstrated the ability to effectively targettumors, which might suggest increased credibility for theorganization in its development of cancer therapyproducts," said Robert Littauer, senior vice president,chief financial officer and treasurer of Seattle-basedNeoRx.
Verluma (formerly called OncoTrac) is the onlydiagnostic being developed by NeoRx, which initiallyfocused on that area but for years has been following astrategy in therapeutics. Littauer said NeoRx won'tdevelop further diagnostic indications for the technology.But since the antibody binds to a number of tumors, othercompanies may be interested in supporting additionalwork, he said.
In a Phase III trial Verluma provided overall stagingaccuracy similar to a battery of four traditional tests.Verluma correctly staged 82 percent of patients withnewly diagnosed SCLC and identified 77 percent of thosewith an extensive stage of disease.
NeoRx is scheduled to receive $4.5 million upon productapproval from The Dupont Merck Pharmaceutical Co.,which has North American rights. Boehringer IngelheimGmbH, of Ingelheim, Germany, has all manufacturingrights and marketing rights outside North America. n
-- Jim Shrine
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