FDA Approves Evista To Reduce Invasive Breast Cancer Risk In Postmenopausal Women With Osteoporosis

Evista (raloxifene HCl), a drug aimed at reducing invasive breast cancer risk for both postmenopausal women with osteoporosis and postmenopausal women with a invasive breast cancer risk has been approved by the US Food and Drug Administration (FDA) for both groups of women.


Gwen Krivi, Ph.D., VP, Lilly Research Laboratories "The FDA's decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns -- osteoporosis and invasive breast cancer. Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."


Evista, which was recently classified as an estrogen agonist/antagonist by the FDA, is a SERM (selective estrogen receptor modulator). It already exists for the prevention/treatment of osteoporosis in postmenopausal women. Two months ago the Oncologic Drugs Advisory Committee (ODAC) voeted for the two new uses to be approved - the FDA, as it did on this occasion, usually goes along with what the committee (advisory panel) recommends.


The decision to approve Evista for this new indication, says makers Eli Lilly, was based on data submitted last year in an NDA (new drug application), which evaluated clinical results from about 37,000 women over a period of ten years; all the women were postmenopausal.


A recent trial found that Evista does not raise the incidence of stroke, but does the incidence of death due to stroke. A boxed warning now says "women with an active or past history of venous thromboembolism should not take EVISTA.. Women at risk for stroke should receive EVISTA only after evaluating the risk-benefit balance with their healthcare providers."


Dr. Lawrence Wickerham, M.D., associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), associate professor of human oncology at Drexel University School of Medicine, said "Thousands of women each year are diagnosed with invasive breast cancer. Today's (14th September) approval of EVISTA for these new uses gives postmenopausal women at risk for this disease an important new treatment option that allows them to take a proactive approach to reducing their risk."


According to the American Cancer Society, about 180,000 women are diagnosed with invasive breast cancer each year.


-- Important Safety Information About EVISTA®


Important Limitations of Use for Breast Cancer Risk Reduction


EVISTA is indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. EVISTA does not treat existing breast cancer, reduce the risk of getting breast cancer again or reduce the risk of all forms of breast cancer.


evista





View drug information on Evista.

FDA Approves Watson's Generic Version Of Barr's Contraceptive Pill Seasonale; Both Companies To Launch Generic Versions

FDA on Thursday approved Watson Pharmaceuticals' marketing application for its generic version of Barr Laboratories' extended-cycle oral contraceptive Seasonale, Reuters reports. A Barr subsidiary also will launch a generic version, to be sold under the name Jolessa (Reuters, 9/7). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003. Women take 84 active pills consecutively and then take seven placebo pills, compared with the usual regimen of 21 active pills followed by seven placebos. The U.S. Patent and Trademark Office in May denied Barr's request to reissue its patent on Seasonale. Barr's subsidiary Duramed Pharmaceuticals received a nonfinal rejection notice from the patent office, which gave the company three months to reply to issues raised by the government before the company's three-year product exclusivity expired on Sept. 5 (Kaiser Daily Women's Health Policy Report, 5/15). Watson -- which in 2004 filed a marketing application with FDA saying that Duramed's Seasonale patent was unenforceable and void -- announced it will immediately launch its product, which will be sold under the name Quasense, MarketWatch reports. According to MarketWatch, Watson is the first pharmaceutical company to successfully challenge Barr's patent on Seasonale and will have market exclusivity for 180 days (Pritchard, MarketWatch, 9/7).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


View drug information on Seasonale, Lo Seasonale, Seasonique.

Rates In Risk Factor For Breast Cancer, Atypical Ductal Hyperplasia, Fell In Line With Hormone Therapy Decline, US Study

Researchers in the US found that the decline in use of postmenopausal hormone therapy may partly explain the fall in incidence of a known risk factor
for breast cancer, atypical ductal hyperplasia. They also said their findings support the idea that low and high grade breast cancers develop via different pathways and thereby clarify the role that hormone therapy may play in increasing the rates of breast cancer.


The study was the work of first author Dr Tehillah Menes, and colleagues and is published in the November issue of Cancer Epidemiology,
Biomarkers & Prevention, a journal of the American Association for Cancer Research.


Menes, who during the study was the chief of breast service in the Department of Surgery at Elmhurst Hospital Center, New York, told the press
that:


"Postmenopausal hormone treatment is associated with increased rates of benign breast biopsies, and early and late stages of cancer."


"Atypical ductal hyperplasia is associated with the use of postmenopausal hormone treatment and its rates have decreased with the decline in use of
this treatment," she added.


Atypical ductal hyperplasia occurs when abnormal cells start to grow in the milk ducts of the breast and other studies suggest the condition is
linked to a three to five-fold increased risk of developing breast cancer.


For this investigation, Menes and colleagues used data from more than 2.4 million mammography studies with and without breast cancer taken between 1996
and 2005. The data came from the Breast Cancer Surveillance Consortium, which gathers information from a network of seven mammography
registries with links to tumor and/or pathology registries in various parts of the US.


Their aim was to examine risk factors and rates of atypical ductal hyperplasia with and without associated breast cancer over time. They also looked at
tumor characteristics of breast cancer with and without associated atypical ductal hyperplasia in women previously screened with
mammography.


The results showed that:

A total of 2,453,483 screening mammograms were linked to 1,064 biopsies with atypical ductal hyperplasia (ADH), 833 breast cancers with
ADH, and 8,161 cancers with no ADH.

Postmenopausal hormone therapy use decreased significantly from 35 per cent to 11 per cent over the study period.

Rates of ADH decreased from a peak of 5.5 per 10,000 mammograms in 1999 to 2.4 per 10,000 in 2005.

Rates of cancer with ADH decreased from a peak of 4.3 per 10,000 mammograms in 2003 to 3.3 per 10,000 in 2005.

ADH and breast cancer were significantly linked to postmenopausal use of hormone therapy.

Cancer linked with ADH was of lower grade and stage and more estrogen receptor positive than cancer without ADH.

Menes and colleagues concluded that postmenopausal hormone therapy is linked with an increased risk of ADH with or without cancer, and
that:


"Rates of ADH have decreased over the past decade, which may be partially explained by the significant reduction in use of postmenopausal HT
[hormone therapy]."


Co-author Dr Karla Kerlikowske, who is professor of medicine and epidemiology and biostatistics at University of California, San Francisco,
said:


"The rate of atypical hyperplasia declined, which we didn't expect to see with the increased use of mammography to identify abnormal
lesions."


"We did not expect to find a decline in rate of atypical ductal hyperplasia with a decline in postmenopausal hormone treatment use," she
added.


The finding that cancer linked with atypical ductal hyperplasia is usually of lower grade and stage supports the theory that low and high grade cancers
develop via separate pathways, said Menes.


"These findings help clarify the different pathways to the development of breast cancer and the role of postmenopausal hormone treatment in
increasing the rates of breast cancer," she concluded.


Kerlikowske suggested future research should concentrate on the effect of hormone therapy on benign proliferative breast lesions.


"Rates of Atypical Ductal Hyperplasia Have Declined with Less Use of Postmenopausal Hormone Treatment: Findings from the Breast Cancer
Surveillance Consortium."

Tehillah S. Menes, Karla Kerlikowske, Shabnam Jaffer, Deborah Seger, and Diana L. Miglioretti.

Cancer Epidemiol Biomarkers Prev,
November 2009 18:2822-2828

DOI:10.1158/1055-9965.EPI-09-0745


Source: American Association for Cancer Research.



: Catharine Paddock, PhD

Editorials, Opinion Pieces Respond To Executive Order Easing Restrictions On Embryonic Stem Cell Research

Newspapers recently published the following editorials and opinion pieces discussing President Obama's decision on Monday to lift some federal restrictions on embryonic stem cell research.

~ New York Times: Obama's move to ease some of former President George W. Bush's restrictions on embryonic stem cell research "ends a long, bleak period in which moral objections of religious conservatives were allowed to constrain the progress of a medically important science," a Times editorial says. It adds that for other promising stem cell research efforts to receive federal funding, Congress also "must lift a separate ban that it has imposed every year since the mid-1990s." The editorial continues, "With the end of the Bush restrictions, scientists receiving federal money will be able to work with hundreds of stem cell lines that have since been created -- and many more that will be created in the future." However, "[o]ther important embryonic research is still being hobbled by the so-called Dickey-Wicker amendment," which is regularly attached to HHS appropriation bills and prohibits the use of federal funds for research that involves the creation or destruction of embryos, according to the editorial. "Until that changes, scientists who want to create embryos -- and extract stem cells -- matched to patients with specific disease will have to rely on private or state support," the editorial says. It concludes, "Congress should follow Mr. Obama's lead and lift this prohibition so such important work can benefit from an infusion of federal dollars" (New York Times, 3/10).

~ Washington Post: A Washington Post editorial says that Obama did "the right thing" in rescinding some of Bush's restrictions on embryonic stem cell research. However, "this type of experimentation is thick with ethical and moral questions, many of which Mr. Obama put off answering," the editorial adds. According to the editorial, Obama "offered little indication" of how he would enforce guidelines on how embryos would be obtained and used, including if research will be "performed only on stem cell lines grown from the thousands of frozen embryos in fertility clinics that have been slated for destruction." The editorial also asks, "Where does [Obama] stand on growing human embryos for experimentation in general and using them for stem cells in particular?" It concludes, "Some of these ethical questions need to be dealt with in the political arena, and not just by scientists" (Washington Post, 3/10).

~Yuval Levin, Washington Post: Obama's executive order "inadvertently cast a bright light on a dangerous temptation in science policy that ought to give Americans pause," Levin, a fellow at the Ethics and Public Policy Center and executive director of the President's Council on Bioethics from 2003 to 2005, writes in a Post opinion piece. He continues, "[W]hile Obama promised that his policy would be bound by ethical guidelines, he left it to the scientists of the National Institutes of Health to define the rules. The issue, he suggested, is a matter of science, not politics." However, "science policy is not just a matter of science," Levin writes, adding, "Like all policy, it calls for a balancing of priorities and concerns and requires a judgment of needs and values that in a democracy we trust to our elected officials." Levin argues that "to govern the practice of scientific techniques that threaten to violate important moral boundaries is not only legitimate but in some cases essential." According to Levin, the president "argues not for an ethical judgment regarding the moral worth of human embryos but, rather, that no ethical judgment is called for: that it is all a matter of science." He continues that "[t]his is a dangerous misunderstanding," adding, "It is the role of elected policymakers to consider the knowledge that science offers and the power it gives us, and to balance these with other priorities." He concludes, "Science is a glorious thing, but it is no substitute for wisdom, prudence or democracy" (Levin, Washington Post, 3/10).














~USA Today: "Obama's move was a necessary and overdue step to advance research that has the potential to regenerate damaged organs and might one day provide a cure for ... debilitating diseases," according to a USA Today editorial. It adds, "More broadly, it sends an important signal about getting politics out of the laboratory." The editorial continues, "Obama's executive order is not a green light for all research on embryos. Since 1996, Congress has enacted a yearly ban, known as the Dickey-Wicker amendment, on spending tax dollars to create embryos." According to the editorial, "It is up to Congress to decide whether it should be overturned," while the "answer to that question depends on whether existing embryos ... and stem cell lines are sufficient, or whether more are needed to advance research." The editorial notes that "[p]olls show 2-to-1 support for embryonic stem cell research," concluding, "Obama's order doesn't guarantee medical breakthroughs, but it makes them more likely" (USA Today, 3/10).

~ Tony Perkins, USA Today: Instead of "increasing funding for stem cell research that is actually treating patients," Obama has decided to "open federal funding to controversial research that requires the destruction of human embryos," Perkins, president of the Family Research Council, writes in a USA Today opinion piece. According to Perkins, "Since November 2007, Japanese and U.S. scientists have used reprogramming to turn normal cells into embryonic-like stem cells that are identical to embryonic stem cells, without using human embryos or cloning. Researchers call these cells induced pluripotent stem cells, or iPSCs." He writes that "the president has chosen to reignite the waning debate over the use of human embryos," adding, "This is both unwise and unnecessary." Perkins says, "Instead of funding speculative embryo research, the federal government should increase funding for stem cell research that is even now treating patients for dozens of serious conditions." He writes that "Congress should refocus resources on what is working now, by increasing funding for cord blood and other types of adult stem cell research," adding that the "best way to do so" is to approve legislation sponsored by Reps. J. Randy Forbes (R-Va.) and Daniel Lipinski (D-Ill.). "Putting patients first is a strategy we can all embrace," Perkins concludes (Perkins, USA Today, 3/10).



Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2009 The Advisory Board Company. All rights reserved.

Vigorous Exercise Reduces Breast Cancer Risk In African-American Women

Vigorous exercise of more than two hours per week reduces the risk of developing breast cancer in postmenopausal African-American women by 64 percent, compared to women of the same race who do not exercise, according to researchers at Georgetown Lombardi Comprehensive Cancer Center.


Results were presented at the Third AACR Conference on The Science of Cancer Health Disparities, held Sept. 30 to Oct. 3, 2010.


"People often want to know what they can do to reduce their risk of disease, and we have found that just two or more hours of vigorous activity per week can made a difference in one's risk of developing breast cancer," said the lead researcher Vanessa Sheppard, Ph.D., a cancer control scientist and assistant professor in the department of oncology at the Lombardi Comprehensive Cancer Center.


In this study, more than two hours of aerobics, running or similar activity over the span of a week counted as vigorous activity.


"We also know from other studies that being physically active can have benefits in other diseases that occur at high rates in African-American women, such as diabetes and hypertension," Sheppard said. "Four out of five African-American women are either overweight or obese, and disease control is a particularly important issue for them."


Evidence showing exercise reduces breast cancer risk has been inconsistent, and there are few that look specifically at African-American women, Sheppard said. The issue is important, she added, because breast cancer has some important differences in this community. Whereas more white women are diagnosed with breast cancer, African-American women have a higher risk of developing premenopausal breast cancer than white women do, and comparatively more African-American women develop the most aggressive form of the disease, known as triple-negative breast cancer.


The researchers identified 97 recently diagnosed African-American breast cancer patients in the Washington, D.C., area and matched them with 102 African-American women without breast cancer. Participants filled out a questionnaire about exercise routines; the responses were analyzed and compared.


Women who exercised vigorously for more than two hours a week in the past year had a 64 percent reduced risk of breast cancer compared to women who did not exercise. Women who engaged in moderate exercise, like walking, had a 17 percent reduced risk, compared to women who were sedentary.


After evaluating those who were pre- and postmenopausal, they found that vigorous exercise only significantly benefitted postmenopausal women they had a 62 percent reduction in risk.


"I was surprised that we did not find a significant effect in premenopausal women, but it may be because we need a larger sample," Sheppard said.


However, when the researchers examined the effect of total physical activity, which combined walking with vigorous activity of two or more hours per week, they saw significant gains for both premenopausal and postmenopausal women.


"We suggest that our findings, while promising, should be interpreted with caution. This is a pilot study and a larger, more rigorous study is needed to precisely quantify the effect of exercise on development of breast cancer. I think it is fair to conclude that if African American women exercise they can help take charge of their health," said Sheppard.


Source: American Association for Cancer Research (AACR)