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SGO perspective on olaparib approval
The U.S. Food and Drug Administration announced Dec. 19 that it has granted accelerated approval to the oral PARP inhibitor, olaparib, in women with recurrent ovarian cancer who carry a germline mutation in the BRCA genes. The announcement establishes a new class of therapy for these patients, and the BRCA analysis test, used for years to identify mutations in the BRCA genes, is the first laboratory-developed test (designed, manufactured and used in a single laboratory) to receive FDA approval as a companion diagnostic test for therapy. Olaparib's approval was based on an observed objective response rate of 34 percent in 137 germline carriers who had received 3 or more lines of prior chemotherapy. The median duration of response was nearly 8 months and no new safety signals emerged from this dataset. Usage under the new label will be limited to women with ovarian cancer who have a BRCA mutation as identified by the BRCA analysis test and in whom 3 or more lines of chemotherapy have been administered. In June 2014, FDA’s Oncologic Drugs Advisory Committee (ODAC) reviewed olaparib for the indication of maintenance therapy following response to platinum-based chemotherapy for recurrent ovarian cancer. Citing concerns in study conduct and potential long term toxicities, ODAC voted not to recommend olaparib for accelerated approval in that indication. However, data supplied to FDA shortly after the ODAC opinion was convincing in meeting their benchmark of a therapeutic producing an effect on a surrogate endpoint likely to produce a clinical benefit. Results from ongoing and completed clinical trials will be evaluated for safety and efficacy before full approval is granted.
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SGO NEWS


Support the Foundation for Gynecologic Oncology
As the end of the year approaches, consider the different ways that you can support the work of the Foundation for Gynecologic Oncology, which is focused on raising money for the needs of the SGO members. This includes researching and recognizing high-quality, affordable treatments for gynecologic cancers and identifying how the healthcare system can best support delivery of this care.
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OVARIAN CANCER


Combining images and genetic data proves gene loss behind aggressive ovarian cancers
Medical Xpress
Cancer Research U.K. scientists have shown that loss of a gene called PTEN triggers some cases of an aggressive form of ovarian cancer, called high-grade serous ovarian cancer, according to a study published in Genome Biology. In a revolutionary approach the researchers from the Cancer Research U.K. Cambridge Institute made the discovery by combining images from cancer samples with genetic data. They proved conclusively that loss of PTEN was commonly found only in the cancerous cells and not the 'normal' cells that help make up the tumor mass.
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MORCELLATION


Health Canada calls for warning label on hysterectomy tool
The Wall Street Journal (Subscription Required)
Canada’s national health regulator has told companies that sell a surgical tool used in hysterectomies that they should add warnings saying the devices could spread and worsen hidden uterine cancers. The move by Health Canada was included in a notice to hospitals on Dec. 10, about two weeks after the U.S. Food and Drug Administration issued a similar directive to U.S. manufacturers.
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CERVICAL CANCER


Decline in cervical cancer death rate ends
Managed Care
The number of deaths caused by cervical cancer remained stubbornly stable from 2007 to 2011. Millions of women do not use simple screening procedures, according to the Centers for Disease Control and Prevention. About 8 million women between 21 and 65 in 2012 hadn’t had a Pap smear in five years, and only 1 in 3 girls and 1 in 7 boys get the three-dose HPV vaccine for children ages 11–12. Current guidelines say that women over 21 should get a Pap smear every three years. More than 12,000 American women get cervical cancer each year, and about 4,000 die from the disease. “Up to 93 percent of cervical cancers are preventable,” the CDC says in its report, “Vital Signs.”
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HEALTH POLICY


CMS to consider covering HPV testing for cervical cancer
AAFP
Earlier this year, the AAFP sent a letter requesting that CMS initiate a national coverage analysis (NCA) for cervical cancer screening in women ages 30-65 that would involve a combination of cytology (Pap smear) and human papillomavirus (HPV) testing every five years — and the agency now has responded to that request in the affirmative.
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Do we need a surgeon general?
MedPage Today
Recently, Vivek Murthy, MD was confirmed as the 19th Surgeon General of the U.S. With the variety of public health issues facing the country, MedPage Today asked health policy experts and a diverse group of healthcare professionals their views on the matter.
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GYNECOLOGIC CANCERS


The year in gynecologic cancer: Bevacizumab and beyond
Medscape (Free login required)
Probably the single most important paper in cervical cancer was the publication of the results of the Gynecologic Oncology Group study that examined the clinical utility of adding the antiangiogenic agent bevacizumab to cytotoxic chemotherapy in the management of recurrent or metastatic cervical cancer. The chemotherapy backbone was cisplatin plus paclitaxel or topotecan plus paclitaxel.
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Top Ob/Gyn controversies from 2014
Medscape (Free login required)
The field of women's health and OB/GYN rarely lacks controversy, and 2014 has been no exception. I've chosen to focus on screening mammograms, routine pelvic exams, and morcellation. I will conclude by introducing a new app for practitioners and our menopausal patients.
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Women's Cancer News
Colby Horton, Vice President of Publishing, 469.420.2601
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Jessica Taylor, Senior Medical Editor, 202-684-7169  
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