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FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Advocacy > Current Actions > FDA Review of Olaparib

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5/23/17
FORCE joined The Ad Hoc Group for Medical Research, representing over 300 organizations, in recommending a $2 billion FY18 increase for NIH, in addition to funds included in the 21st Century Cures Act for targeted initiatives.

5/12/17
Advocate Melanie Nix shares why she is passionate about health policy efforts. Read her blog...

4/25/17
FORCE VP of Advocacy is in NY today participating in the Basser Center for BRCA's "The Intersection of Cancer Genetics, Law and Advocacy" event.

3/30/17
FORCE joined Harvard, several patient advocacy orgs and pharma companies to submit FDA comments regarding the voluntary provision of plain language summaries of aggregate results to research subjects.

3/28/17
FORCE is on Capitol Hill today...part of a CIBR Medical Technology Showcase team presenting on new cancer imaging technology & fighting for research funding.

3/21/17
Today FORCE met with Senate HELP committee staff to discuss concerns about H.R. 1313. Read more...

2/22/17
FORCE participated in NCI's “Approaches to Blue Ribbon Panel Recommendations: The Case of Lynch Syndrome" Workshop.
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FDA Review of Olaparib

Unfortunately, ODAC voted against approval of olaparib at the conclusion of the June 25, 2014 hearing. While olaparib showed improvement in progression-free survival, it did not show an improvement in overall survival for the women who took it in the clinical trials. Because there are no approved maintenance drugs currently on the market for ovarian cancer, the trials compared the side effects of olaparib to a placebo (i.e. no treatment at all). Olaparib had more side effects and adverse events than the placebo, so the advisory committee decided the benefits didn't outweigh the risks.

The panel did not take into account the fact that taking olaparib delays a woman's need to go back on chemotherapy; a treatment shown to be more toxic than olaparib. While this vote is not the final decision, the FDA will likely follow ODAC's recommendation and the therapy will be reconsidered after the conclusion of additional research. See our blog about this decision and learn more about PARP inhibitors.

Page updated 7/28/14

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