ANSWERS
05/15/1996

<TITLE>FDA APPROVES TAXOTERE FOR BREAST CANCER</TITLE>
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T96-32                                    Susan M. Cruzan
May 15, l996                              301-443-3285


             FDA Approves Taxotere for Breast Cancer

     We are receiving inquiries about the approval of Taxotere
(docetaxel) for breast cancer.  The new drug is indicated for
patients whose advanced breast cancer has progressed despite
treatment with drugs such as doxorubicin, a part of standard
cancer treatment regimens.  The following may be used to respond
to questions.  
     An estimated 184,300 new cases of breast cancer are
diagnosed in the U.S. each year.  This year, an estimated 44,300
women will die of the disease nationwide.  Drugs such as
doxorubicin is of benefit for many patients with advanced breast
cancer.  Taxotere was found to produce responses in some patients
even after doxorubicin therapy was no longer effective.  
     Taxotere, a semi-synthetic drug is derived from the needles
of the yew plant.  Taxotere's approval was based on several phase
2 studies including three trials in the United States and Europe
which demonstrated that the drug can shrink tumors in some breast
cancer patients.  At the highest tested dose, the drug shrank
tumors in 42 percent of patients for an average of six months. 
     Trials using a lower dose showed that the drug shrank tumors
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                    Page 2, T96-32, Taxotere for Breast Cancer 
in 35 percent of patients for four months with fewer adverse 
effects than those associated with the higher dose.
     Taxotere, like many cancer drugs, is associated with serious
side effects including a decrease in white blood cell counts,
fluid retention, allergic reactions, and hair loss.  While the
higher dose of the drug is also associated with more severe cases
of fluid retention and skin toxicity, these effects were
negligible at the lower dose.  Taxotere is given by infusion in
one hour treatments about every three weeks. 
     The drug's labeling warns that patients should be pre-
medicated to prevent problems with fluid retention and allergic
reactions.  Certain patients with liver dysfunction should not
use Taxotere. 
     Taxotere has been granted an accelerated approval -- a
regulatory mechanism which bases early approval for a product on
clinical improvements such as shrinkage of a tumor, rather than
survival time or quality of life.  By basing accelerated approval
on these partial responses, and allowing more definitive data to
be developed on clinical endpoints after approval, FDA is giving
patients earlier access to more promising cancer therapies. 
     FDA may withdraw the approval of such products if post-
marketing studies fail to verify clinical benefits.  Larger,
longer term trials testing Taxotere's clinical benefits are
ongoing.
                             -More-


                 Page 3, T96-32, Taxotere for Breast Cancer
  Taxotere will be marketed by Rhone-Poulenc Rorer Inc. of
Collegeville, Pa.  Taxotere should not be confused with Taxol,
another cancer drug marketed by Bristol Myers Squibb Oncology and
also derived from the yew tree to treat ovarian and breast
cancer.
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