Answers
04/21/1994

<TITLE>Taxol Approved for Breast Cancer</TITLE>
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T94-24                                   Susan M. Cruzan
April 21, l994                           (301) 443-3285

                Taxol Approved for Breast Cancer

     We are receiving inquiries about the approval of Taxol for
breast cancer when standard chemotherapy has failed.  In December
l992, FDA approved Taxol for treatment of ovarian cancer that has
not responded to standard  chemotherapy.  The following may be used
to answer questions.
     On April 13, l994, FDA approved a supplemental application for
Taxol for treatment of metastatic breast cancer in patients who
have not responded to first line chemotherapy or who have relapsed
after chemotherapy.  The approved label states that the drug is
indicated for "breast cancer after failure of combination
chemotherapy for metastatic disease or relapse within six months of
adjuvant chemotherapy.  Prior therapy should have included an
anthracycline unless clinically contraindicated."  Anthracycline
drugs such as doxorubicin (Adriamycin) are among the drugs of
choice for treatment of breast cancer.
     Although Taxol does not cure unresponsive breast cancer, 
several early studies and a large multicenter trial found it to be
effective in shrinking tumors.  In a multicenter randomized trial
of 471 patients in Canada and Europe, Taxol decreased tumor size by
one half in 26 percent of patients.  These patients remained stable
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                                         Page 2, T94-24, Taxol
for an average of eight months from the start of treatment.  The
average survival time following treatment with Taxol was 11.7
months.   
     While Taxol is beneficial in some cases, it has serious side
effects.  The more serious side effects include neutropenia -- a
decrease in white blood cells which may increase susceptibility to
infections -- hair loss, and numbness of the fingers and toes.   
Taxol (paclitaxol), extracted from yew tree bark, is currently
marketed by Bristol-Myers Squibb of Wallingford, Conn.   
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