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17:13 DJ =DJ FDA Panel Rejects Liposome's Evacet For Breast Cancer
By Otesa Middleton
WASHINGTON (Dow Jones)--A federal panel failed to back Liposome Co.'s (LIPO)
version of the common chemotherapy drug doxirubicin to treat spreading breast
cancer.
The drug, an injection called Evacet, encapsulates the doxirubicin in a fat
bubble called a liposome in an effort to protect healthy cells until the
medicine reaches the tumor.
The panel's recommendation will be considered when the Food and Drug
Administration decides if it will approve Evacet.
Liposome is asking the FDA approve Evacet, used in combination with the drug
cyclophosphamide, as an initial treatment for metastatic, spreading breast
cancer. The company told the panel patients in its studies were able to
tolerate higher doses of Evacet than the conventional form of doxirubicin
because the liposomal form reduced the amount of serious side effects,
particularly heart failure.
Dr. Lily Lee, a vice president at Liposome, told the panel one of the
company's studies showed when compared to conventional doxirubicin, Evacet
patients responded to the drug at the same rate.
However, the drug reduced the risk of heart damage by 75% to 80%.
"Doxirubicin is a mainstay of treatment for breast cancer, but it is
associated with well-documented cardiac toxicity that can be permanently
disabling and potentially fatal," Lee said.
Evacet patients also had fewer incidents of other side effects, including
diarrhea, she said.
Dr. Gerald Batist, of the Jewish General Hospital at McGill University, spoke
to the panel on the company's behalf.
"(Evacet) dramatically reduces cardiotoxicity without bringing any added
toxicities," Batist said.
Panelist Dr. David H. Johnson, director of medical oncology at Vanderbilt
University Medical School in Nashville, said Evacet seems to have somewhat
less cardiac toxicity. However, Johnson said he isn't convinced Evacet is as
effective as regular doxirubicin.
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