Panel vote on label change for raloxifene
- From: MarilynMann <mannm@xxxxxxxxxxx>
- Date: Sun, 29 Jul 2007 13:35:19 -0700
Panel Says Lilly's Evista
Cuts Breast-Cancer Risk
By JENNIFER CORBETT DOOREN
July 25, 2007; Page D2
WASHINGTON -- A Food and Drug Administration panel backed a request by
Eli Lilly & Co. to tell women that its osteoporosis drug Evista also
cuts the risk of getting breast cancer, despite concerns about such
side effects as blood clots.
The panel of outside medical experts said the drug was more likely to
be effective for women considered at high risk for developing breast
cancer.
The panel voted 10-4 in favor of allowing Lilly to relabel Evista as
cutting the "risk of invasive breast cancer in women at high risk for
breast cancer." The panel on an 8-6 vote backed a proposal to state
the drug cuts breast-cancer risk "in postmenopausal women with
osteoporosis."
The votes amount to a recommendation that the FDA approve Lilly's
request to relabel Evista as a breast-cancer risk-reduction drug,
which would also let the company market the drug for that use. The FDA
usually follows its panel's advice but isn't required to do so.
Lilly, of Indianapolis, presented four studies in support of Evista's
ability to reduce the risk of breast cancer, including results of a
large National Cancer Institute study that is looking at Evista and an
older drug, tamoxifen, in relation to preventing breast cancer.
The study, which is following 19,747 postmenopausal women, showed that
both Evista, known generically as raloxifene, and tamoxifen cut the
risk of women developing breast cancer by 50%. Tamoxifen was approved
in 1998 to prevent breast cancer in women at high risk of developing
the disease.
In real terms, however, the actual reduction in the number of breast
cancer cases isn't as large as the risk reduction. FDA medical
reviewers said studies showed about 300 to 800 women would have to be
treated with Evista for one year to prevent one case of breast cancer.
The FDA said Evista appeared to carry fewer side effects than
tamoxifen but that both drugs carried a risk of serious side effects.
* * *
Raloxifene increases the risk of venous thromboembolism and fatal
stroke. I can see using it to lower the risk of recurrence in women
who have been treated for breast cancer. For women who are otherwise
at high risk of breast cancer, I don't really know.
There's no free lunch with any of the drugs for osteoporosis or
prevention of breast cancer.
A clinical trial of aromatase inhibitors for prevention of breast
cancer in healthy women was recently cancelled. They figured women
wouldn't take them anyway because of the side effects.
Marilyn
.
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