ANSWERS
08/20/1996

<TITLE> FDA LICENSES DIAGNOSTIC IMAGING AGENT FOR LUNG CANCER
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T96-56                                  Lenore Gelb
August 20, 1996                         (301) 443-3285


      FDA LICENSES DIAGNOSTIC IMAGING AGENT FOR LUNG CANCER

     FDA today licensed a new diagnostic imaging agent that can
determine the extent of disease in patients diagnosed with small
cell lung cancer (SCLC).  Because this agent can detect tumors in
different parts of the body at one time, it can help physicians
advise certain patients with advanced forms of the disease about
treatment options without requiring further diagnostic tests.     
     The new agent, Nofetumomab, is a fragment of a monoclonal
antibody that when tagged with the radioisotope technetium, can
detect a protein found on the surface of most small cell lung
cancers.  The Nofetumomab imaging kit is approved for use in
patients who have been diagnosed with SCLC through a confirmed
biopsy, but who have not yet received treatment.  The product
should only be used once, and should not be used to rule out
suspected lung cancer or its spread in patients without confirmed
SCLC.  It also should not be used to evaluate the effectiveness
of subsequent treatment.         
     This biotechnology product is made by genetically
engineering mouse spleen cells to make monoclonal antibodies that
react with the protein on small cell lung cancers.  A fragment of 
this antibody is chemically modified so it will bind to
radioactive technetium.  In patients injected with the product,
the radiolabeled monoclonal antibody collects in several areas of
the body including certain tumor sites.  These sites are
visualized as "hotspots" using special cameras.  The images are
used to help physicians identify whether patients have limited or
extensive disease and in turn, to help determine prognosis and
therapeutic options.     
     In the clinical trial involving 89 patients with confirmed
SCLC, technetium-labeled Nofetumomab accurately determined
whether the disease was extensive or limited 82 percent of the
time.  If the test indicated extensive disease, the result was
true in 94 percent of the patients.  However, if the test
indicated limited disease, it was less valuable as a diagnostic
aid, failing to image tumors in some body organs in approximately
23 percent of patients.  Because of these false negative
readings, additional standard diagnostic tests, such as a bone or
computerized tomography scan (CT scan), or a bone marrow biopsy
should be performed when limited disease is found.         
     Each year in the United States, approximately 30,000 new
cases of SCLC are diagnosed.  Of those who are found to have
extensive disease, the median survival is 33 weeks and only 1 to
3 percent of patients survive more than three years.  In
contrast, up to 20 percent of patients with limited disease may
survive more than three years.  
     The Nofetumobab kit is manufactured by Dr. Karl Thomae GmbH,
affiliated with Boehringer-Ingelheim International, Ingelheim,
Germany.  It will be distributed under the trade name Verluma by
the Dupont Merck Pharmaceutical Company, Billerica,
Massachusetts.
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