FDA Approves 2 Diagnostic Tests, Acts on Eulexin Application

ROCKVILLE, Md--In recent actions, the FDA approved two new diagnostictests--for bladder cancer and colorectal cancer--and extendedthe indications for an antiandrogen agent in the treatment ofprostate cancer.

The agency gave final approval for Matritech's NMP22 Test Kitfor use in identifying patients at risk for bladder cancer recurrence.The kit is the first nuclear matrix protein (NMP)-based diagnosticproduct to receive FDA clearance.

The test kit, a urine assay for transitional cell carcinoma ofthe urinary tract, which accounts for more than 95% of all bladdercancers, has been found in clinical trials to be twice as sensitiveas urine cytology, the company said, and has the added benefitof delaying and reducing the number of cystoscopies needed infollow-up care for patients at risk.

Said Daniel B. Rukstalis, MD, of the Medical College of Pennsylvania,who participated in the NMP22 trials, "a low NMP22 value10 days after surgery enables near-90% certainty that my patientwill not have a malignancy at 3-month follow-up cystoscopy."Conversely, he said, an elevated value gives a high degree ofcertainty that the patient likely will have a recurrence at the3-month follow-up, "which enables me to react quickly, therebyimproving the prognosis."

CEA-Scan Imaging for Colon Ca

Immunomedics, Inc. has received clearance to market CEA-Scan (Arcitum-omab),a diagnostic imaging product for colorectal cancer. The CEA-Scanis the first technetium-labeled antibody and the first small antibodyfragment licensed for diagnostic imaging in the United States.

The assay is to be used in conjunction with standard diagnosticmethods, including CT scan, as a means of detecting the presence,location, and extent of recurrent and/or metastatic colorectalcancer in the abdominopelvic region. The product provides additionalinformation in patients with no evidence of disease by standarddiagnostic methods, and in whom there is a suspicion of cancerrecurrence or spread.

A retrospective analysis of the company's phase III study resultssuggests that CEA-Scan can be useful in evaluating patients inwhom surgical interventions, such as exploratory laparotomy andsurgical resection, are under consideration.

Said David M. Goldenberg, MD, chairman and CEO of New Jersey-basedImmunomedics, "by identifying about twice as many patientswho cannot be cured by surgery and about 40% more patients whoare operable for potential cure, CEA-Scan may have a very importantimpact on the management of colorectal cancer."

The product will be launched in the fall by Immunomedics, in collaborationwith the Mallinckrodt Group, Inc., after training of nuclear physiciansand education programs for cancer specialists.

Eulexin Supplemental Application

Schering-Plough Corporation's anti-androgen Eulexin (flutamide),currently marketed in the United States for the treatment of advanced(stage D2) prostate cancer in combination with LHRH agonists,has received clearance for the treatment of locally confined stageB2-C prostate cancer in combination with LHRH agonists and radiationtherapy. Approval came only 6 months after submission of the supplementalapplication.

The application for the expanded indication was based on a multicentercontrolled clinical study conducted by the Radiation Therapy OncologyGroup (RTOG) in which Eulexin in combination with an LHRH agonistwas administered prior to and during radiation therapy to patientswith prostate cancer at stage B2 (bulky primary tumors confinedto the prostate) and stage C (extending beyond the prostate capsule),with or without pelvic node involvement. The trial involved 466patients.

The results showed that the combined Eulexin therapy significantlyincreased median disease-free survival (4.4 years vs 2.6 yearsfor radiation alone) and significantly lowered the local failurerate (16% vs 33% at 4 years).